Phase 2
N=65
Alzheimer's Disease: Potential Benefit of Isoflavones
Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00205179 ↗Enrolled (actual)
65
Serious AEs
6.2%
Results posted
Jan 2020
Primary outcome: Primary: Cognitive Outcomes - Language Executive Function : Category Fluency Assessed as Number of Words Generated/Min — 21.5; 25.7 number of words generated per minute
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Novasoy (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cognitive Outcomes - Language Executive Function : Category Fluency Assessed as Number of Words Generated/Min |
21.5; 25.7 | — |
| PRIMARY Cognitive Outcomes - Language Executive Function : Phonemic Fluency/Verbal Fluency Assessed as Number of Words Generated Per Minute |
25.9; 35.2 | — |
| PRIMARY Immediate and Delayed Recall on Verbal Memory/ List Learning Immediate and Delayed Free Recall: Number of Words Recalled |
1.8; 2.2 | — |
| PRIMARY Immediate and Delayed Recall on Verbal Memory/ Logical Memory Immediate and Delayed Recall: Number of Story Elements Recalled |
4.6; 5.7 | — |
| PRIMARY Measure of Divided Attention: Time to Complete Trail Making Test B |
95.5; 95.7 | — |
| PRIMARY A Test of Planning: Time to Complete Mazes |
32.2; 22.6 | — |
| PRIMARY Measure of Selective Attention: Time to Complete Stroop Color Word Test |
105; 91.8 | — |
| PRIMARY Visual Memory Test: Complex Figure Delayed Recall; Number of Points |
10.6; 13.4 | — |
| PRIMARY Visual Memory : Benton Visual Retention Test: Number of Correct Figures |
2.7; 2.8 | — |
| PRIMARY Cognitive Outcomes - Visual Memory : Benton Visual Retention; Number of Errors |
14.5; 13.1 | — |
| SECONDARY Cognitive Outcomes - Visual Motor : Complex Figure Copy; Number of Points |
27.6; 29.0 | — |
| SECONDARY Cognitive Outcomes - Visual Motor : Time to Complete Grooved Pegboard Test Using the Dominant Hand |
134.3; 149.8 | — |
| SECONDARY Cognitive Outcomes - Visual Motor : Time to Complete Grooved Pegboard Test Using the Non-Dominant Hand |
161.8; 156 | — |
| SECONDARY Cognitive Outcomes-Global Cognition : Mini-Mental State Examination (MMSE) Score |
21.3; 23.4 | — |
| SECONDARY Multiple Mood States: Profile of Mood States (POMS)-Depression Scale |
9; 11.4 | — |
| SECONDARY Multiple Mood States: Profile of Mood States (POMS)-Tension Scale |
8.2; 9.3 | — |
| SECONDARY Multiple Mood States: Profile of Mood States (POMS)-Anger Scale |
6.8; 8.3 | — |
| SECONDARY Multiple Mood States: Profile of Mood States (POMS)-Fatigue Scale |
10.3; 10.3 | — |
| SECONDARY Multiple Mood States: Profile of Mood States (POMS)-Vigor Scale |
12.4; 12.0 | — |
| SECONDARY Multiple Mood States: Profile of Mood States (POMS)-Confusion Scale |
15.5; 14 | — |
| SECONDARY Geriatric Depression Scale-Subject Report |
2.1; 3.3 | — |
| SECONDARY Geriatric Depression Scale-Study Partner Report |
5.2; 6.3 | — |
| SECONDARY Number of Participants With ApoE4 Allele |
15; 16 | — |
| SECONDARY Plasma Concentrations of Isoflavones at Baseline |
4.8; 1.5; 2.8; 1.3; 0.3; 0.1 | — |
| SECONDARY Plasma Concentrations of Isoflavones at Month 3 |
2.1; 2777.7; 1.1; 197.3; 0.2; 20.3 | — |
| SECONDARY Plasma Concentrations of Isoflavones at Month 6 |
15.6; 338.6; 10.6; 206.6; 0.1; 19.6 | — |
| SECONDARY Plasma Concentrations of Estradiol at Baseline |
— | — |
| SECONDARY Plasma Concentrations of Estradiol at 3 Month |
— | — |
| SECONDARY Plasma Concentrations of Estradiol at 6 Month |
— | — |
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 ( 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
Data sourced from ClinicalTrials.gov (NCT00205179). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.