Effects of a caregiver intervention on negative caregiver appraisals of behavior problems in patients with Alzheimer's disease: results of a randomized trial. Health Behavior Changes After Genetic Risk Assessment for Alzheimer Disease: The REVEAL Study Tolerability and safety of Souvenaid in patients with mild Alzheimer's disease: results of multi-center, 24-week, open-label extension study. Exercise training for depressed older adults with Alzheimer's disease Adjunctive treatment with high frequency repetitive transcranial magnetic stimulation for the behavioral and psychological symptoms of patients with Alzheimer's disease: a randomized, double-blind, sham-controlled study Medication development for agitation and aggression in Alzheimer disease: review and discussion of recent randomized clinical trial design. Medication adherence survey of drugs useful in prevention of dementia of Alzheimer's type among Indian patients. Long-Term Efficacy and Safety of Celecoxib in Alzheimer’s Disease Effects of cardiovascular medications on rate of functional decline in Alzheimer disease. Mediterranean diet and Alzheimer disease mortality Explaining behavior change after genetic testing: the problem of collinearity between test results and risk estimates. Multistimulation Group Therapy in Alzheimer’s Disease Promotes Changes in Brain Functioning Would you want to know? Public attitudes on early diagnostic testing for Alzheimer's disease A supervised method to assist the diagnosis and monitor progression of Alzheimer's disease using data from an fMRI experiment Quality of life of community-residing persons with dementia based on self-rated and caregiver-rated measures Women and Menopause: Beliefs, Attitudes, and Behaviors. The North American Menopause Society 1997 Menopause Survey Knowledge and beliefs about help-seeking behavior and helpfulness of interventions for Alzheimer's disease Training community consultants to help family members improve dementia care: a randomized controlled trial. Effectiveness of a computerized drug-monitoring program to detect and prevent adverse drug events and medication non-adherence in outpatient ambulatory care: study protocol of a randomized controlled trial Efficacy of a medical food on cognition in Alzheimer’s Disease: Results from secondary analyses of a randomized, controlled trial Motivational Interviewing and Cognitive-Behavioral Intervention to Improve HIV Medication Adherence Among Hazardous Drinkers: A Randomized Controlled Trial Amyloid negativity in patients with clinically diagnosed Alzheimer disease and MCI Effects of testosterone on cognition and mood in male patients with mild Alzheimer disease and healthy elderly men.
Behavioral problems are among the most challenging aspects of caring for a person with Alzheimer 's disease . A sample of 406 spouses-caregivers of patients with Alzheimer 's disease was r and omized to an active multicomponent counseling and support intervention condition or to a usual care condition . Caregivers reported on the frequency of troublesome patient behaviors and their reactions to them at baseline and at regular follow-up interviews . R and om-effects regression models over the first 4 years after r and omization revealed that , although the intervention did not affect the frequency of patient behavioral problems , it did significantly reduce caregivers ' reaction ratings . Because caregiver appraisal s have been found to mediate the impact of caregiving stress on depression and to predict nursing home placement rates , they deserve greater attention as an important target of intervention services Risk information for Alzheimer disease ( AD ) may be communicated through susceptibility gene disclosure , even though this is not currently in clinical use . The REVEAL Study is the first r and omized clinical trial of risk assessment for AD with apolipoprotein E ( APOE ) genotype and numerical risk estimate disclosure . We examined whether APOE genotype and numerical risk disclosure to asymptomatic individuals at high risk for AD alters health behaviors . One hundred sixty-two participants were r and omized to either intervention ( APOE disclosure ) or control ( no genotype disclosure ) groups . Subjects in both groups received numerical lifetime risk estimates of future AD development based on sex and family history of AD . The intervention group received their APOE genotype . Subjects were informed that no proven preventive measures for AD existed and given an information sheet on preventative therapies under investigation . Participants who learned they were ϵ4 positive were significantly more likely than ϵ4 negative participants to report AD-specific health behavior change 1 year after disclosure ( adjusted odds ratio : 2.73 ; 95 % confidence interval : 1.14 , 6.54 ; P=0.02 ) . Post hoc analyses revealed similar significant associations between numerical lifetime risk estimates and self-report of AD-specific health behavior change . Despite lack of preventive measures for AD , knowledge of APOE genotype , numerical lifetime risk , or both , influences health behavior BACKGROUND The medical food Souvenaid , containing the specific nutrient combination Fortasyn Connect , is design ed to improve synapse formation and function in patients with Alzheimer 's disease ( AD ) . Two double-blind r and omized controlled trials ( RCT ) with Souvenaid of 12 and 24 week duration ( Souvenir I and Souvenir II ) showed that memory performance was improved in drug-naïve mild AD patients , whereas no effects on cognition were observed in a 24-week RCT ( S-Connect ) in mild to moderate AD patients using AD medication . Souvenaid was well-tolerated in all RCTs . OBJECTIVE In this 24-week open-label extension ( OLE ) study to the 24-week Souvenir II RCT , long-term safety and intake adherence of the medical food Souvenaid was evaluated . METHODS Patients with mild AD ( n = 201 ) received Souvenaid once-daily during the OLE . Main outcome parameters were safety and product intake adherence . The memory domain z-score from a revised neuropsychological test battery was continued as exploratory parameter . RESULTS Compared to the RCT , a similar ( low ) incidence and type of adverse events was observed , being mainly ( 68.3 % ) of mild intensity . Pooled data ( RCT and OLE ) showed that 48-week use of Souvenaid was well tolerated with high intake adherence ( 96.1 % ) . Furthermore , a significant increase in the exploratory memory outcome was observed in both the active-active and control-active groups during Souvenaid intervention . CONCLUSION Souvenaid use for up to 48-weeks was well tolerated with a favorable safety profile and high intake adherence . The findings in this OLE study warrant further investigation toward the long-term safety and efficacy of Souvenaid in a well-controlled , double-blind RCT The purpose of this study was to compare the effects of 16 weeks of a comprehensive exercise routine to supervised walking and social conversation on depression in nursing home residents with Alzheimer 's disease ( AD ) . Method : This study was a three-group , repeated- measures design with r and om assignment to treatment group . Forty-five nursing home residents with moderate to severe AD were r and omly assigned to a 16-week programme of comprehensive exercise , supervised walking or social conversation . Raters were blinded to treatment group assignment . Major outcome variables were depression measured by the Cornell Scale for Depression in Dementia , mood measured by the Dementia Mood Assessment Scale and the Alzheimer 's Mood Scale , and affect measured by the Observed Affect Scale . Depression was reduced in all three groups with some evidence of superior benefit from exercise .  Depression is a common problem with serious and costly consequences for nursing home residents with AD .  Exercise as a behavioural approach to treatment of depression in nursing home residents with severe AD evidence d a clear benefit to participants in this study . More research is needed to clarify the relative benefits of different types of exercise in conjunction with or without pharmacological intervention Background Behavioral and psychological symptoms of dementia ( BPSD ) occur in 70 - 90 % of patients at different stages of Alzheimer ’s Disease ( AD ) , but the available methods for managing these problems are of limited effectiveness . Aim Assess the effects of high-frequency repetitive transcranial magnetic stimulation ( rTMS ) , applied over the left dorsolateral prefrontal cortex ( DLPFC ) , on BPSD and cognitive function in persons with AD . Methods Fifty-four patients with AD and accompanying BPSD were r and omly divided into an intervention group ( n=27 ) and a control group ( n=27 ) . In addition to st and ard antipsychotic treatment , the intervention group was treated with 20Hz rTMS five days a week for four weeks , while the control group was treated with sham rTMS.The  Behavioral Pathology in Alzheimer 's Disease Rating Scale ( BEHAVE-AD ) , the Alzheimer 's Disease Assessment Scale-Cognitive ( ADAS-Cog ) , and the Treatment Emergent Symptom Scale ( TESS ) were administered by raters who were blind to the group assignment of patients before and after four weeks of treatment . Results Twenty-six subjects from each group completed the study . After four weeks of antipsychotic treatment with adjunctive real or sham rTMS treatment , the mean ( sd ) total BEHAVE-AD scores and mean total ADAS-Cog scores of both groups significantly decreased from baseline . After adjusting for baseline values , the intervention group had significantly lower scores ( i.e. , greater improvement ) than the control group on the BEHAVE-AD total score , on five of the seven BEHAVE-AD factor scores ( activity disturbances , diurnal rhythm , aggressiveness , affective disturbances , anxieties and phobias ) , on the ADAS-Cog total score , and on all four ADAS-Cog factor scores ( memory , language , constructional praxis , and attention ) . The proportion of individuals whose behavioral symptoms met a predetermined level of improvement ( i.e. , a drop in BEHAVE-AD total score of > 30 % from baseline ) in the intervention group was greater than that in the control group ( 73.1 % vs.42.3 % , X2=5.04 , p=0.025 ) . Conclusion Compared to treatment of AD with low-dose antipsychotic medications alone , the combination of low-dose antipsychotic medication with adjunctive treatment with high frequency rTMS can significantly improve both cognitive functioning and the behavioral and psychological symptoms that often accompany AD ABSTRACT Background : The management of disruptive neuropsychiatric symptom ( NPS ) such as agitation and aggression ( A/A ) is a major priority in caring for people with Alzheimer 's disease ( AD ) . Few effective pharmacological or non-pharmacological options are available . Results of r and omized clinical trials ( RCTs ) of drugs for A/A have been disappointing . This may result from the absence of biological efficacy for medications tested in treating A/A. It may also be related to method ological issues such as the choice of outcomes . The aim of this review was to highlight key method ological issues pertaining to RCTs of current and emerging medications for the treatment of A/A in AD . Methods : We search ed PubMed / Medline , Cochrane Central Register of Controlled Trials , and Clinical Trials.gov for RCTs comparing medications with either placebo or other drugs in the treatment of A/A in AD , between January 2008 and December 2013 . Results : We identified a total of 18 RCTs ; of these , 11 were completed and 7 ongoing . Of the ongoing RCTs , only one is in Phase III . Seven of 10 completed RCTs with reported results did not report greater benefit from drug than placebo . Each of the completed RCTs used a different definition of " clinical ly significant A/A. " There was considerable heterogeneity in study design . The primary endpoints were largely proxy-based but a variety of scales were used . The definition of caregiver and scales used to assess caregiver outcomes were similarly heterogeneous . Placebo response was notable in all trials . Conclusions : This review highlights a great heterogeneity in RCTs design of drugs for A/A in AD and some key method ological issues such as definition of A/A , choice of outcome measures and caregiver participation that could be addressed by an expert consensus to optimize future trials design BACKGROUND Good medication adherence is the cornerstone of therapeutic success . Alzheimer 's disease ( AD ) is the most common type of dementia and most patients are old and on multiple drugs , and good compliance therefore is even more important in this population . Dementia of Alzheimer 's type ( DAT ) at present is yet to find a cure . Anticholinesterases and N-methyl-D-aspartate blockers are specific anti-AD therapies available . Hypertension , diabetes , and dyslipidemia can contribute to cognitive worsening . Keeping hypertension , diabetes , and dyslipidemia in control can therefore possibly prevent further cognitive decline . METHODS Patients with subjective memory complaints ( n = 75 ) were chosen r and omly . Upon thorough neurological diagnostic work up for dementia , those with mild cognitive impairment/ question able dementia ( Clinical Dementia Rating = 0.5 ) or those with AD were recruited in this study ( n = 67 ) . Those with hypertension , diabetes , and deranged lipid profile were further interviewed if they were able to take medicines regularly or not . An attempt was made to know causes of non-compliance . RESULTS Forty-one percent of patients were not taking the drugs that have potential to prevent cardiovascular complications or ability to slow down cognitive decline in AD on regular basis . The lack of awareness , ignorance , medicines being " too expensive , " and the pressure of taking medicines regularly were cited as the reasons for non-compliance . Being illiterate and having low education contributed majorly to poor compliance in this study . CONCLUSION Compliance to drugs that have potential or real ability to slow down cognitive decline is low in elderly people with DAT Background / Aims : Cyclooxygenase-2 ( COX-2 ) may play an important role in the neuropathology of Alzheimer ’s disease ( AD ) . The efficacy and safety of celecoxib ( 200 mg bid ) , a COX-2 selective inhibitor , were assessed in patients ≧50 years with established mild-to-moderate AD to determine whether treatment was effective in retarding deterioration of cognitive function . Methods : This was a 52-week , multicenter , r and omized , double-blind , placebo-controlled , parallel-group study . The primary efficacy end points were the change from baseline to week 52 in the Alzheimer ’s Disease Assessment Scale-Cognitive Behavior ( ADAS-cog ) composite score and the week 52 Clinician ’s Interview-Based Impression of Change Plus ( CIBIC+ ) . Results : At 52 weeks , change in ADAS-cog scores from baseline was similar for placebo and celecoxib 200 mg bid groups ( 5.00 and 4.39 , respectively ) . CIBIC+ scores were also similar ( 4.83 and 4.92 ) . Two extension studies were conducted but were terminated early based on these efficacy results . Safety data from all 3 studies indicated that celecoxib was generally well-tolerated . Conclusion : Celecoxib 200 mg bid did not slow the progression of AD in this study , and the occurrence of adverse events was as expected for an elderly population with a complex chronic medical condition BACKGROUND Evidence suggests that cardiovascular medications , including statins and antihypertensive medications , may delay cognitive decline in patients with Alzheimer dementia ( AD ) . We examined the association of cardiovascular medication use and rate of functional decline in a population -based cohort of individuals with incident AD . METHODS In the Dementia Progression Study of the Cache County Study on Memory , Health , and Aging , 216 individuals with incident AD were identified and followed longitudinally with in-home visits for a mean of 3.0 years and 2.1 follow-up visits . The Clinical Dementia Rating ( CDR ) was completed at each follow-up . Medication use was inventoried during in-home visits . Generalized least-squares r and om-effects regression was performed with CDR Sum of Boxes ( CDR-Sum ) as the outcome and cardiovascular medication use as the major predictors . RESULTS CDR-Sum increased an average of 1.69 points annually , indicating a steady decline in functioning . After adjustment for demographic variables and the baseline presence of cardiovascular conditions , use of statins ( p = 0.03 ) and beta-blockers ( p = 0.04 ) was associated with a slower annual rate of increase in CDR-Sum ( slower rate of functional decline ) of 0.75 and 0.68 points respectively , while diuretic use was associated with a faster rate of increase in CDR-Sum ( p = 0.01 ; 0.96 points annually ) . Use of calcium-channel blockers , angiotensin-converting enzyme inhibitors , digoxin , or nitrates did not affect the rate of functional decline . CONCLUSIONS In this population -based study of individuals with incident AD , use of statins and beta-blockers was associated with delay of functional decline . Further studies are needed to confirm these results and to determine whether treatment with these medications may help delay AD progression Background : We previously reported that the Mediterranean diet ( MeDi ) is related to lower risk for Alzheimer disease ( AD ) . Whether MeDi is associated with subsequent AD course and outcomes has not been investigated . Objectives : To examine the association between MeDi and mortality in patients with AD . Methods : A total of 192 community-based individuals in New York who were diagnosed with AD were prospect ively followed every 1.5 years . Adherence to the MeDi ( 0- to 9-point scale with higher scores indicating higher adherence ) was the main predictor of mortality in Cox models that were adjusted for period of recruitment , age , gender , ethnicity , education , APOE genotype , caloric intake , smoking , and body mass index . Results : Eighty-five patients with AD ( 44 % ) died during the course of 4.4 ( ±3.6 , 0.2 to 13.6 ) years of follow-up . In unadjusted models , higher adherence to MeDi was associated with lower mortality risk ( for each additional MeDi point hazard ratio 0.79 ; 95 % CI 0.69 to 0.91 ; p = 0.001 ) . This result remained significant after controlling for all covariates ( 0.76 ; 0.65 to 0.89 ; p = 0.001 ) . In adjusted models , as compared with AD patients at the lowest MeDi adherence tertile , those at the middle tertile had lower mortality risk ( 0.65 ; 0.38 to 1.09 ; 1.33 years ' longer survival ) , whereas subjects at the highest tertile had an even lower risk ( 0.27 ; 0.10 to 0.69 ; 3.91 years ' longer survival ; p for trend = 0.003 ) . Conclusion : Adherence to the Mediterranean diet ( MeDi ) may affect not only risk for Alzheimer disease ( AD ) but also subsequent disease course : Higher adherence to the MeDi is associated with lower mortality in AD . The gradual reduction in mortality risk for higher MeDi adherence tertiles suggests a possible dose-response effect This paper explores whether and how the behavioral impact of genotype disclosure can be disentangled from the impact of numerical risk estimates generated by genetic tests . Secondary data analyses are presented from a r and omized controlled trial of 162 first-degree relatives of Alzheimer 's disease ( AD ) patients . Each participant received a lifetime risk estimate of AD . Control group estimates were based on age , gender , family history , and assumed epsilon4-negative apolipoprotein E ( APOE ) genotype ; intervention group estimates were based upon the first three variables plus true APOE genotype , which was also disclosed . AD-specific self-reported behavior change ( diet , exercise , and medication use ) was assessed at 12 months . Behavior change was significantly more likely with increasing risk estimates , and also more likely , but not significantly so , in epsilon4-positive intervention group participants ( 53 % changed behavior ) than in control group participants ( 31 % ) . Intervention group participants receiving epsilon4-negative genotype feedback ( 24 % changed behavior ) and control group participants had similar rates of behavior change and risk estimates , the latter allowing assessment of the independent effects of genotype disclosure . However , collinearity between risk estimates and epsilon4-positive genotypes , which engender high-risk estimates , prevented assessment of the independent effect of the disclosure of an epsilon4 genotype . Novel study design s are proposed to determine whether genotype disclosure has an impact upon behavior beyond that of numerical risk estimates Background . The growing social emergency represented by Alzheimer ’s disease ( AD ) and the lack of medical treatments able to modify the disease course have kindled the interest in nonpharmacological therapies . Objective . We introduced a novel nonpharmacological approach for people with AD ( PWA ) named Multidimensional Stimulation group Therapy ( MST ) to improve PWA condition in different disease domains : cognition , behavior , and motor functioning . Methods . Enrolling 60 PWA in a mild to moderate stage of the disease , we evaluated the efficacy of MST with a r and omized-controlled study . Neuropsychological and neurobehavioral measures and functional magnetic resonance imaging ( fMRI ) data were considered as outcome measures . Results . The following significant intervention-related changes were observed : reduction in Neuropsychiatric Inventory scale score , improvement in language and memory subscales of Alzheimer ’s Disease Assessment Scale – Cognitive subscale , and increased fMRI activations in temporal brain areas , right insular cortex , and thalamus . Conclusions . Cognitive-behavioral and fMRI results support the notion that MST has significant effects in improving PWA cognitive-behavioral status by restoring neural functioning Introduction Research is underway to develop an early medical test for Alzheimer 's disease ( AD ) . Methods To evaluate potential dem and for such a test , we conducted a cross-sectional telephone survey of 2,678 r and omly selected adults across the United States and four European countries . Results Most surveyed adults ( 67 % ) reported that they are " somewhat " or " very likely " to get an early medical test if one becomes available in the future . Interest was higher among those worried about developing AD , those with an immediate blood relative with AD , and those who have served as caregivers for AD patients . Older respondents and those living in Spain and Pol and also exhibited greater interest in testing . Knowing AD is a fatal condition did not influence dem and for testing , except among those with an immediate blood relative with the disease . Conclusions Potential dem and for early medical testing for AD could be high . A predictive test could not only advance medical research , it could transform political and legal l and scapes by creating a large constituency of asymptomatic , diagnosed adults OBJECTIVE The aim of this work is to provide a supervised method to assist the diagnosis and monitor the progression of the Alzheimer 's disease ( AD ) using information which can be extracted from a functional magnetic resonance imaging ( fMRI ) experiment . METHODS AND MATERIAL S The proposed method consists of five stages : ( a ) preprocessing of fMRI data , ( b ) modeling of the fMRI voxel time series using a generalized linear model , ( c ) feature extraction from the fMRI experiment , ( d ) feature selection , and ( e ) classification using the r and om forests algorithm . In the last stage we employ features that were extracted from the fMRI and other features such as demographics , behavioral and volumetric measures . The aim of the classification is twofold : first to diagnose AD and second to classify AD as very mild and mild . RESULTS The method is evaluated using data from 41 subjects . The stage of AD is established using the Washington University Alzheimer 's Disease Research Center recruitment and assessment procedures . The method classifies a patient as healthy or demented with 84 % sensitivity and 92.3 % specificity , and the stages of AD with 81 % and 87 % accuracy for the three class and the four class problem , respectively . CONCLUSIONS The method is advantageous since it is fully automated and for the first time the diagnosis and staging of the disease are addressed using fMRI Purpose To identify correlates of  self-rated and caregiver-rated quality of life ( QOL )  in community-residing persons with dementia ( PWD ) for intervention development . Methods Cross-sectional data of 254 PWD and their caregivers participating in a clinical trial were derived from in-home assessment s.  Self-rated QOL  was measured with the  Quality of Life-Alzheimer Disease ( QOL-AD ) scale  , and  caregiver-rated QOL  was measured using the  QOL-AD  and  Alzheimer Disease-Related Quality of Life ( ADRQL ) scales . Multivariate modeling identified correlates of the PWD ’ QOL . Results Self-rated QOL was related significantly to participant race , unmet needs , depression , and total medications . Caregiver-rated QOL-AD scores were significantly associated with participant function , unmet needs , depression , and health problems and with caregiver burden and self-rated health . Significant correlates of ADRQL scores included neuropsychiatric symptom severity , functional and cognitive impairment , and caregiver burden and depression . Conclusions Correlates of QOL in community-residing PWD depend on who rates the PWD ’s QOL and which measure is used . Addressing health problems , medication use , and dementia-related unmet needs , reducing functional dependency , and treating neuropsychiatric symptoms in PWD , while reducing caregiver burden and depression , may maximize QOL in those with dementia OBJECTIVE The main purpose in organizing this survey was to collect information relevant to The North American Menopause Society 's ( NAMS ) educational mission and to document women 's knowledge of , and attitudes toward , menopause . DESIGN During June-July 1997 , The Gallup Organization conducted 750 telephone interviews with a r and omly selected sample of women 45 - 60 years of age from across the United States . Women were asked about their sources of information on menopause , what changes in health they anticipated as a result of menopause , why they used hormone therapy , and their attitudes toward menopause as a natural or a medical event . RESULTS Women are more likely to believe that depression and irritability are associated with menopause than heart disease , but only a few associate menopause with an increasing vulnerability to either memory loss or Alzheimer 's disease . Relief of physical symptoms of menopause was mentioned as the reason for starting hormone therapy more often than to protect against osteoporosis ( 25 % relative to 15 % ) , or to prevent stroke or a heart attack ( 10 % ) , or to reduce the risk of developing Alzheimer 's disease ( 2 % ) . The single main source of women 's information on menopause was a health professional ( 49 % ) . The majority of women who were already menopausal or experiencing menstrual changes expressed an attitude toward menopause that was either neutral ( 42 % ) or positive ( 36 % ) . CONCLUSIONS Women are divided in their views of menopause , some seeing it as a medical condition requiring medical treatment , whereas others see it as a natural transition to be managed by " natural " means . Providing women with accurate , up-to- date information and enhancing communication between healthcare providers and menopausal women remain the challenges for NAMS Objective : We investigated the lay public 's attitudes toward help seeking and preferences for treatment of Alzheimer 's disease ( AD ) in the city of São Paulo , Brazil . Method : Cross-sectional population -based r and om sample of 500 household residents over 18 years old participated in face-to-face interviews in São Paulo , which included a case vignette depicting AD and a structured question naire . Results : Public opinion rests firmly in the lay support system . Psychologists and self-help groups and close relatives were often rated as helpful . Many alternative treatments ( such as vitamins , physical exercise , vacation ) were often rated as helpful . Limited education , younger age and experience with psychiatric problems are associated with the ‘ medical ’ intervention model . Female sex and middle age are associated with ‘ alternative ’ interventions . Conclusion : Our results suggest that attitudes and belief systems have an important impact on help-seeking and treatment recommendations PURPOSE We investigated whether community consultants could be trained to teach family caregivers a systematic behavioral approach for reducing mood and behavior problems in persons with Alzheimer 's disease . DESIGN AND METHODS This study consisted of a r and omized controlled trial ; we r and omly assigned 95 family caregivers and care recipients with Alzheimer 's disease to STAR-caregivers ( STAR-C ) or control groups . Masked interviewers conducted assessment s at baseline , after treatment , and after 6 months . Consultants were master's-level health care professionals who were currently practicing in community setting s serving older adults . We assessed the extent to which consultants were able to learn and adhere to the treatment protocol , and the relationship between adherence and measures of caregiver mood , burden , and care recipient mood and behavior . RESULTS Community consultants were able to learn and adhere to the behavioral treatment protocol . Caregivers receiving STAR-C training showed significant improvements in depression , burden , and reactivity to behavior problems in the care recipient . There were also significant reductions in the frequency and severity of care recipient behavior problems , and improved quality of life . Results were maintained at 6-month follow-up . IMPLICATION S Community-based consultants successfully implemented a behavioral intervention with family caregivers of persons with Alzheimer 's disease . Consequently , STAR-C seems to be a practicable and reasonable evidence d-based approach to caregiver training in actual clinical setting Background Medications are an effective intervention for managing and preventing health problems but their benefit can be undermined by non-adherence or adverse drug events ( ADEs ) . Since these issues may be interconnected , efforts to improve non-adherence should also include reduction of ADEs . We have developed the ISTOP-ADE system ( Information Systems-enabled Outreach for Preventing Adverse Drug Events ) , which enables timely monitoring and managing of ADEs . The objectives of this study are to determine whether the ISTOP-ADE system , compared to routine care , will reduce : a ) the probability of discontinuing the use of prognosis-altering medications ; b ) the probability of a patient experiencing a severe ADE ; c ) the proportion of patients experiencing ADEs , preventable ADEs and ameliorable ADEs ; and d ) health services utilization . Methods / design We will r and omly assign 2,200 adult ambulatory patients in the province of Québec who have been prescribed an incident medication for the management or prevention of a chronic health condition , to routine care or the ISTOP-ADE system .  The ISTOP-ADE system consists of an interactive voice response system ( IVRS ) paired with pharmacist support . The IVRS will call patients at 3 and 17 days post-prescription to determine if they are experiencing any problems and connect them with a pharmacist when required or desired by the patient . We will evaluate medication persistence at 180 days and health-care utilization using provincial administrative data . Two blinded physicians will ascertain ADE status through a case review . Discussion We expect the ISTOP-ADE intervention to be feasible and to improve the quality of patient care through improved medication adherence , reduced ADE duration and reduced number of ADEs result ing in an emergency department or inpatient encounter . This in turn could lower health-care utilization , saving costs and lowering the burden on emergency departments and family practice s. The success of ISTOP-ADE would present opportunities to implement this intervention through health systems , health insurance agents and commercial pharmacies . Trial registration Clinical Trials.gov Identifier : NCT02059044 . Date registered : 10 January 2014 Objective To investigate the extent that baseline cognitive impairment and intake adherence affected the 13-item Alzheimer ’s Disease Assessment Scale — cognitive subscale ( ADAS-cog ) intervention response of a medical food in Alzheimer ’s Disease ( AD ) patients .Desigrt/ setting / participants /intervention/ measurements This analysis was performed on data from a proof-of-concept study , consisting of a 12-week , double-blind , r and omized , controlled , multicenter trial , followed by a similarly design ed 12-week extension study . Patients with mild AD ( Mini-Mental State Examination [ MMSE ] score of 20–26 ) were r and omized to receive active or control product as a 125 ml daily drink . One of the co- primary outcome measures was the 13-item ADAS-cog . In this analysis , the study population was divided into two subgroups : patients with ‘ low ’ baseline ADAS-cog scores ( < 25.0 ) and patients with ‘ high baseline ADAS-cog scores ( ≥25.0 ) . Repeated Measures Models ( RMM ) were used to determine the relationship between ADAS-cog score and intervention . Results A significant treatment effect ( F[1,319]=4.0 , p=0.046 ) was shown in patients with ‘ high baseline ADAS-cog , but not in patients with ‘ low ’ baseline ADAS-cog ( F[1,250]= 1.25 , p=0.265 ) . Overall , intake adherence was significantly correlated with ADAS-cog improvement in the active product group ( correlation coefficient=−0.260 ; p=0.019 ) , but not the control group . Conclusion These data indicate that baseline ADAS-cog significantly influenced the effect of Souvenaid intervention on ADAS-cog outcome . A higher intake of active study product was also associated with greater cognitive benefit . These findings highlight the potential benefits of Souvenaid in AD patients and warrant confirmation in larger , controlled studies Objective : To assess the efficacy of a behavioral intervention design ed to improve HIV medication adherence and reduce alcohol consumption among HIV-positive men and women . Design : A r and omized controlled trial conducted between July 2002 and August 2005 . Setting : A behavioral research center in New York City . Participants : HIV-positive men and women ( n = 143 ) who were on HIV antiretroviral medication and met criteria for hazardous drinking . Intervention : Participants were r and omly assigned to an 8-session intervention based on motivational interviewing and cognitive-behavioral skills building or a time- and content-equivalent educational condition . Outcome Measures : Viral load , CD4 cell count , and self-reported adherence and drinking behavior were assessed at baseline and at 3- and 6-month follow-ups . Results : Relative to the education condition , participants in the intervention demonstrated significant decreases in viral load and increases in CD4 cell count at the 3-month follow-up and significantly greater improvement in percent dose adherence and percent day adherence . There were no significant intervention effects for alcohol use , however , and effects on viral load , CD4 cell count , and adherence were not sustained at 6 months . Conclusions : An 8-session behavioral intervention can result in improvement in self-report and biologic markers of treatment adherence and disease progression . This type of intervention should be considered for dissemination and integration into HIV clinics providing comprehensive care for HIV-positive persons with alcohol problems . Although the effect was attenuated over time , future studies might test the added effectiveness of booster sessions or ongoing adherence counseling Objective : To examine the clinical and biomarker characteristics of patients with amyloid-negative Alzheimer disease ( AD ) and mild cognitive impairment ( MCI ) from the Alzheimer 's Disease Neuroimaging Initiative ( ADNI ) , a prospect i ve cohort study . Methods : We first investigated the reliability of florbetapir− PET in patients with AD and patients with MCI using CSF-Aβ1–42 as a comparison amyloid measurement . We then compared florbetapir− vs florbetapir+ patients with respect to several AD-specific biomarkers , baseline and longitudinal cognitive measurements , and demographic and clinician report data . Results : Florbetapir and CSF-Aβ1–42 + /− status agreed for 98 % of ADs ( 89 % of MCIs ) , indicating that most florbetapir− scans were a reliable representation of amyloid status . Florbetapir− AD ( n = 27/177 ; 15 % ) and MCI ( n = 74/217 , 34 % ) were more likely to be APOE4-negative ( MCI 83 % , AD 96 % ) than their florbetapir+ counterparts ( MCI 30 % , AD 24 % ) . Florbetapir− patients also had less AD-specific hypometabolism , lower CSF p-tau and t-tau , and better longitudinal cognitive performance , and were more likely to be taking medication for depression . In MCI only , florbetapir− participants had less hippocampal atrophy and hypometabolism and lower functional activity question naire scores compared to florbetapir+ participants . Conclusions : Overall , image analysis problems do not appear to be a primary explanation of amyloid negativity . Florbetapir− ADNI patients have a variety of clinical and biomarker features that differ from their florbetapir+ counterparts , suggesting that one or more non-AD etiologies ( which may include vascular disease and depression ) account for their AD-like phenotype CONTEXT There is a compelling need for therapies that prevent , defer the onset , slow the progression , or improve the symptoms of Alzheimer disease ( AD ) . OBJECTIVE To evaluate the effects of testosterone therapy on cognition , neuropsychiatric symptoms , and quality of life in male patients with mild AD and healthy elderly men . DESIGN Twenty-four-week , r and omized , double-blind , placebo-controlled , parallel-group study . SETTING Memory disorders clinics as well as general neurology and medicine clinics from University of California medical centers at Los Angeles , San Francisco , and Irvine . PATIENTS OR OTHER PARTICIPANTS Sixteen male patients with AD and 22 healthy male control subjects . Healthy elderly control men were recruited from the community through advertisements as well as through the university-based clinics . INTERVENTION Testosterone and placebo , in the form of hydroalcoholic gel ( 75 mg ) , were applied daily to the skin of the participants . MAIN OUTCOME MEASURES Instruments assessing cognitive functioning ( Alzheimer 's Disease Assessment Scale-Cognitive Subscale , California Verbal Learning Test , Block Design Subtest , Judgment of Line Orientation , Developmental Test of Visual-Motor Integration ) , neuropsychiatric symptoms ( Neuropsychiatric Inventory ) , global functioning ( Clinician 's Interview-Based Impression of Change ) , and quality of life ( Quality of Life-Alzheimer Disease Scale ) . RESULTS For the patients with AD , the testosterone-treated group had significantly greater improvements in the scores on the caregiver version of the quality -of-life scale ( P = .01 ) . No significant treatment group differences were detected in the cognitive scores at end of study , although numerically greater improvement or less decline on measures of visuospatial functions was demonstrated with testosterone treatment compared with placebo . In the healthy control group , a nonsignificant trend toward greater improvement in self-rated quality of life was observed in the testosterone-treated group ( P = .09 ) compared with placebo treatment . No difference between the treatment groups was detected in the remaining outcome measures . Testosterone treatment was well tolerated with few adverse effects relative to placebo . CONCLUSIONS Results suggest that testosterone replacement therapy improved overall quality of life in patients with AD .  Testosterone had minimal effects on cognition
Results : Intentional factors affecting adherence include patient , caregiver and prescriber beliefs about therapies and the disease itself .
Conclusion : Due to the high level of caregiver involvement in the care of patients with AD , strategies that address caregiver concerns may improve adherence
Background / Aims : Treatment adherence is a major problem in numerous medical conditions , and is a particular challenge in patients with Alzheimer 's disease ( AD ) .