Alzheimer's Disease: Potential Benefit of Isoflavones

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00205179
First received: September 13, 2005
Last updated: September 27, 2010
Last verified: September 2010
  Purpose

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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • biological assays of isoflavones and hormones [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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 ClinicalTrials.gov identifier: NCT00205179

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Carey E Gleason, PhD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: Carey Gleaon, PhD, University of Wisconsin
ClinicalTrials.gov Identifier: NCT00205179     History of Changes
Other Study ID Numbers: 2003-0048, 5K23AG024302-03
Study First Received: September 13, 2005
Last Updated: September 27, 2010
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014