Alzheimer's Disease: Potential Benefit of Isoflavones

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute on Aging (NIA); National Institutes of Health (NIH)

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