Alzheimer's Disease: Potential Benefit of Isoflavones

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00205179
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : October 5, 2015
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Wisconsin, Madison

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 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 or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Novasoy Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : January 2005
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: University of Wisconsin, Madison Identifier: NCT00205179     History of Changes
Other Study ID Numbers: 2003-0048
5K23AG024302-03 ( U.S. NIH Grant/Contract )
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: October 5, 2015
Last Verified: September 2010

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders