Clinical trial NCT02860338: COMPARATIVE EFFECTIVENESS OF MCI and DEMENTIA TREATMENTS IN A COMMUNITY-BASED DEMENTIA PRACTICE
Official title: Retrospective Analysis of the Comparative Effectiveness of MCI and Dementia Treatment Protocols in a Community-based Specialty Dementia Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Cognitive Impairment
Dementia
Hypoxia
Hyperhomocysteinemia
Vitamin B 12 Deficiency
Iron Deficiency
Anemia
TBI
Neurodegenerative Disorders
Alzheimer's Disease
Vascular Dementia
Brain Injuries
Tauopathies
Parkinson's Disease
Lewy Body Dementia
Frontotemporal Dementia
TDP-43 Proteinopathies
Keywords: Psuedobulbar affect, PBA
Lead sponsor: Clionsky Neuro Systems Inc.
Sponsor class: INDUSTRY
First posted: 2016-08-09
Enrollment: 900
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cohort 1: Consecutive patients presenting for care for cognitive impairment in a non-academic, non-hospital based, dementia specialty practice in Springfield, MA Cohort 2: Convenience sample of patients referred to neuropsychological testing and treated by non-dementia specialists in Springfield, MA

Brief summary: This retrospective study is a more extensive, confirmatory analysis of the cognitive and functional outcomes initially seen in 2 groups of MCI/dementia patients in Springfield, MA and compares specialized dementia care and a comprehensive treatment approach versus usual care delivered in a non-specialist setting.

The first group of patients (n= 328) was seen by a dementia specialist, who utilized a standardized assessment and treatment protocol (CNS). This included comprehensive identification and treatment of hypoxia, sleep-disorders, and other cognitively-impairing metabolic conditions as well as maximally- dosed FDA-approved medications for dementia, depression, and PBA.

The second group of patients (n= 280) was seen by non-dementia specialists in the community and received usual care which did not include comprehensive assessment or treatment of underlying metabolic derangements or maximal utilization of currently available medications.

This study, evaluating date from a larger cohort (n\>800) of specialist-treated cognitively-impaired patients, will further examine the hypothesis that a comprehensive dementia treatment protocol yields cognitive stabilization and/or improvement using already available dementia drugs when compared with usual community care.

Detailed description: From 2008-2013 more than 5,000 patients have been seen by a community-based internist/psychiatrist specializing in treating cognitively impaired adults suffering from MCI or dementia due to Alzheimer's Disease, vascular dementia, combined DAT/VAD, FTD, PD, LBD, as well as dementia due to traumatic brain injury (TBI), alcoholism and autoimmune diseases.

Cohort 1 includes patients from this specialist practice who were extensively evaluated with a standardized protocol assessment aimed at identifying all reversible and treatable conditions adversely affecting cognition, and achieving maximum diagnostic accuracy with respect to the underlying dementia pathology. The protocol included physical and mental status examinations, neuroimaging (PET scans and/or MRI's with volumetrics), lab tests, overnight pulse oximetry, in-lab and ambulatory polysomnography, and gold standard neuropsychological testing as well as rapid, in-office cognitive testing. The comprehensive treatment protocol attempted correction of all modifiable and metabolic derangements, and utilized maximally tolerated FDA approved medications and devices.

Cohort 2 includes patients who were referred by their primary care clinicians or other non-dementia specialists to a neuropsychology practice for a standardized cognitive evaluation as part of usual care, but were not treated by a dementia specialist.

This in-depth retrospective analysis is the first attempt to evaluate the comparative effectiveness of dementia drugs and other treatment interventions in a cognitively impaired patient group whose baseline metabolic abnormalities were identified, treated and maintained optimally throughout the course of care versus a patient group not so intensively assessed or managed.

Outcome measures include objective cognitive testing and functional and behavioral assessments correlated with prescribed standard dementia medications, reductions in benzodiazepine, narcotic and antipsychotic use, as well as with baseline and interval measures of oxygenation adequacy, BNP, CRP, IGF-1, homocysteine, methylmalonic acid, iron status, Vitamin D 25-OH, and utilization of oxygen and positive airway pressure treatment.

Eligibility criteria: Inclusion Criteria:

* individuals presenting for assessment and treatment of cognitive impairment, either by self-identification, report by family or caregivers, or upon referral from another physician.

Exclusion Criteria:

* individuals who were not fluent in English and for whom a translator was not available.
* individuals who were blind

Primary outcomes:
measure: Cognitive testing - Memory Orientation Screening Test (MOST)
timeFrame: At each office visit, for 96 months, until patient left the practice, or until date of death
Secondary outcomes:
measure: Resting and ambulatory pulse oximetry in office
timeFrame: At each office visit, for 96 months, until patient left the practice, or until date of death
measure: Nocturnal pulse oximetry
timeFrame: Ordered and Initial office visit or subsequent patient visits, for 96 months, until the patient left the practice, or until the date of death.
measure: Polysomnography in-lab and ambulatory ( in patient's residence)
timeFrame: Initial study ordered at first or subsequent office visit for for 96 months, until the patient left the practice, or until the date of death.
measure: Laboratory values: Chem 20, CBC/diff, BNP, CRP, iron, iron/TIBC, ferritin, homocysteine, methylmalonic acid, Vitamin D 25-OH, RPR/FTA-ABS/TPPA, IGF-1
timeFrame: Ordered at initial and subsequent office visits for 96 months, until patient left the practice, or until date of death
Other outcomes:
measure: Medications - prescribed
timeFrame: Ordered ar Initial office visit and any subsequent visits for Ordered at initial and subsequent office visits for 96 months, until patient left the practice, or until date of death
measure: Oxygen - prescribed
timeFrame: Ordered at either at initial or subsequent office visit for a period of 96 months, or until patient left the practice, or until date of death
measure: Diagnosis: Obstructive/Central/Complex Sleep Apnea CPAP- Continuous Positive Airway Pressure or Bi-PAP
timeFrame: CPAP ordered at either at initial or subsequent office visit for a period of 96 months, or until patient left the practice, or until date of death
measure: Diagnosis: Bradycardia/tachycardia
timeFrame: Recorded at all office visits or overnight testing for a period of 96 months, or until patient left the practice, or until date of death
measure: Discontinuation of cognitively impairing medications or other high risk medications (Beers criteria): benzodiazepines, narcotics, anticholinergics, and antipsychotics
timeFrame: At initial office visit and all subsequent visits for a period of 96 months, or until patient left the practice, or until date of death
Locations:
Study officials:
affiliation: Clionsky Neuro Systems Inc.
name: Emily F Clionsky, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Clionsky MI, Clionsky E. Development and validation of the Memory Orientation Screening Test (MOST): A better screening test for dementia. Am J Alzheimers Dis Other Demen. 2010 Dec;25(8):650-6. doi: 10.1177/1533317510386216.
citation: The Memory Orientation Screening Test accurately separates Normal from MCI and Demented Elder in a prevalence-stratified sample. Journal of Alzheimer's Disease and Parkinsonism. 2013 vol 3(1). http://dx.doi,org/10.4172/2161-04601000109
citation: Clionsky M, Clionsky E. Psychometric equivalence of a paper-based and computerized (iPad) version of the Memory Orientation Screening Test (MOST(R)). Clin Neuropsychol. 2014;28(5):747-55. doi: 10.1080/13854046.2014.913686. Epub 2014 May 12.