Status:
COMPLETED
Alzheimer's Disease: Potential Benefit of Isoflavones
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
55+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00205179
Start Date
January 1 2005
End Date
December 1 2009
Last Update
January 22 2020
Active Locations (1)
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1
University of Wisconsin
Madison, Wisconsin, United States, 53792