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Alzheimer's Disease: Potential Benefit of Isoflavones

This study has been completed.
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
First received: September 13, 2005
Last updated: October 1, 2015
Last verified: September 2010
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
Alzheimer's Disease Drug: Novasoy Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Alzheimer's Disease: Potential Benefit of Isoflavones

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Cognitive Data [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • biological assays of isoflavones and hormones [ Time Frame: 6 months ]

Estimated Enrollment: 60
Study Start Date: January 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
100mg/day soy isoflavones
Drug: Novasoy
100mg/day soy isoflavones
Placebo Comparator: Placebo
100mg/day matching placebo
Drug: Placebo
100mg/day matching placebo


Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00205179

United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
National Institutes of Health (NIH)
Principal Investigator: Carey E Gleason, PhD University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison Identifier: NCT00205179     History of Changes
Other Study ID Numbers: 2003-0048
5K23AG024302-03 ( U.S. NIH Grant/Contract )
Study First Received: September 13, 2005
Last Updated: October 1, 2015

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders processed this record on September 20, 2017