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Sponsors and Collaborators: |
University of Wisconsin, Madison National Institutes of Health (NIH) |
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Information provided by: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT00205179 |
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.
Condition | Intervention | Phase |
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Alzheimer's Disease |
Drug: Novasoy Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
Official Title: | Alzheimer's Disease: Potential Benefit of Isoflavones |
Estimated Enrollment: | 60 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Active: Experimental
100mg/day soy isoflavones
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Drug: Novasoy
100mg/day soy isoflavones
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Placebo: Placebo Comparator
100mg/day matching placebo
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Drug: Placebo
100mg/day matching placebo
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Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kirsten Walth | 866-636-7764 | memory-research@medicine.wisc.edu |
United States, Wisconsin | |
University of Wisconsin | Recruiting |
Madison, Wisconsin, United States, 53792 | |
Contact: Kirsten Walth 866-636-7764 memory-research@medicine.wisc.edu |
Principal Investigator: | Carey E Gleason, PhD | University of Wisconsin, Madison |
Responsible Party: | University of Wisconsin ( Carey Gleaon, PhD ) |
Study ID Numbers: | 2003-0048, 5K23AG024302-03 |
Study First Received: | September 13, 2005 |
Last Updated: | November 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00205179 |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases Neurodegenerative Diseases |
Brain Diseases Dementia Cognition Disorders Delirium |
Nervous System Diseases Tauopathies |