Alzheimer's Disease: Potential Benefit of Isoflavones

University of Wisconsin (UW)

Status and phase

Completed

Phase 2

Conditions

Alzheimer's Disease

Treatments

Drug: Placebo

Drug: Novasoy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00205179

A534255 (Other Identifier)

2003-048

SMPH/MEDICINE/MEDICINE*G (Other Identifier)

5K23AG024302-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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