Clinical trial NCT00205179: Alzheimer's Disease: Potential Benefit of Isoflavones
Official title: Alzheimer's Disease: Potential Benefit of Isoflavones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2005-09-20
Enrollment: 72
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to evaluate the potential effects of soy isoflavone supplements on cognitive function for men and women with Alzheimer's Disease (AD). Preliminary studies evaluating the effects of soy supplements on memory in cognitively healthy older adults have yielded promising results that are now being evaluated in patients with AD. It is hypothesized that isoflavone supplements will ameliorate cognitive declines for older adults diagnosed with Alzheimer's disease, when compared to subjects on placebo.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of probable AD
* Has reliable and available caregiver to assist with medication and appointments
* On a stable dose of cholinesterase inhibitor, or if unable to tolerate medication, patient has no plans to re-initiate cholinergic therapies while in the study

Exclusion Criteria:

* Current or recent use (\<6 months) of menopausal Hormone Replacement Therapy (HRT)
* Current or recent use (\<4 months) or oral antibiotic therapy
* Typical dietary intake of soy isoflavones \>5 mg/day
* History or significant gastro-intestinal or colon disease, or colon/intestinal resection
* Irritable bowel syndrome
* History of breast cancer, or abnormal mammogram within 12 months
* History of chronic obstructive pulmonary disease, diabetes mellitus, liver disease or unstable ischemic heart disease
* Significant neurological disease other than AD that might affect cognitive function, such as stroke, Parkinson's disease, multiple sclerosis, or serious traumatic brain injury

Primary outcomes:
measure: Cognitive Outcomes - Language Executive Function : Category Fluency Assessed as Number of Words Generated/Min
timeFrame: 6 months
measure: Cognitive Outcomes - Language Executive Function : Phonemic Fluency/Verbal Fluency Assessed as Number of Words Generated Per Minute
timeFrame: 6 months
measure: Immediate and Delayed Recall on Verbal Memory/ List Learning Immediate and Delayed Free Recall: Number of Words Recalled
timeFrame: 6 months
measure: Immediate and Delayed Recall on Verbal Memory/ Logical Memory Immediate and Delayed Recall: Number of Story Elements Recalled
timeFrame: 6 months
measure: Measure of Divided Attention: Time to Complete Trail Making Test B
timeFrame: 6 months
measure: A Test of Planning: Time to Complete Mazes
timeFrame: 6 months
measure: Measure of Selective Attention: Time to Complete Stroop Color Word Test
timeFrame: 6 months
measure: Visual Memory Test: Complex Figure Delayed Recall; Number of Points
timeFrame: 6 months
measure: Visual Memory : Benton Visual Retention Test: Number of Correct Figures
timeFrame: 6 months
measure: Cognitive Outcomes - Visual Memory : Benton Visual Retention; Number of Errors
timeFrame: 6 months
Secondary outcomes:
measure: Cognitive Outcomes - Visual Motor : Complex Figure Copy; Number of Points
timeFrame: 6 months
measure: Cognitive Outcomes - Visual Motor : Time to Complete Grooved Pegboard Test Using the Dominant Hand
timeFrame: 6 months
measure: Cognitive Outcomes - Visual Motor : Time to Complete Grooved Pegboard Test Using the Non-Dominant Hand
timeFrame: 6 months
measure: Cognitive Outcomes-Global Cognition : Mini-Mental State Examination (MMSE) Score
timeFrame: 6 months
measure: Multiple Mood States: Profile of Mood States (POMS)-Depression Scale
timeFrame: 6 months
measure: Multiple Mood States: Profile of Mood States (POMS)-Tension Scale
timeFrame: 6 months
measure: Multiple Mood States: Profile of Mood States (POMS)-Anger Scale
timeFrame: 6 months
measure: Multiple Mood States: Profile of Mood States (POMS)-Fatigue Scale
timeFrame: 6 months
measure: Multiple Mood States: Profile of Mood States (POMS)-Vigor Scale
timeFrame: 6 months
measure: Multiple Mood States: Profile of Mood States (POMS)-Confusion Scale
timeFrame: 6 months
measure: Geriatric Depression Scale-Subject Report
timeFrame: 6 months
measure: Geriatric Depression Scale-Study Partner Report
timeFrame: 6 months
measure: Number of Participants With ApoE4 Allele
timeFrame: Baseline
measure: Plasma Concentrations of Isoflavones at Baseline
timeFrame: baseline
measure: Plasma Concentrations of Isoflavones at Month 3
timeFrame: At month 3
measure: Plasma Concentrations of Isoflavones at Month 6
timeFrame: At month 6
measure: Plasma Concentrations of Estradiol at Baseline
timeFrame: baseline
measure: Plasma Concentrations of Estradiol at 3 Month
timeFrame: At 3 month
measure: Plasma Concentrations of Estradiol at 6 Month
timeFrame: At 6 month
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Carey E Gleason, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gleason CE, Carlsson CM, Barnet JH, Meade SA, Setchell KD, Atwood CS, Johnson SC, Ries ML, Asthana S. A preliminary study of the safety, feasibility and cognitive efficacy of soy isoflavone supplements in older men and women. Age Ageing. 2009 Jan;38(1):86-93. doi: 10.1093/ageing/afn227. Epub 2008 Dec 2.
citation: Gleason CE, Fischer BL, Dowling NM, Setchell KD, Atwood CS, Carlsson CM, Asthana S. Cognitive Effects of Soy Isoflavones in Patients with Alzheimer's Disease. J Alzheimers Dis. 2015;47(4):1009-19. doi: 10.3233/JAD-142958.