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

September 13, 2005
September 27, 2010
January 2005
December 2009   (final data collection date for primary outcome measure)
Cognitive Data [ Time Frame: 6 months ] [ Designated as safety issue: No ]
cognitive data
Complete list of historical versions of study NCT00205179 on ClinicalTrials.gov Archive Site
biological assays of isoflavones and hormones [ Time Frame: 6 months ] [ Designated as safety issue: No ]
biological assays of isoflavones and hormones
Not Provided
Not Provided
 
Alzheimer's Disease: Potential Benefit of Isoflavones
Alzheimer's Disease: Potential Benefit of Isoflavones

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: Novasoy
    100mg/day soy isoflavones
  • Drug: Placebo
    100mg/day matching placebo
  • Experimental: Active
    100mg/day soy isoflavones
    Intervention: Drug: Novasoy
  • Placebo Comparator: Placebo
    100mg/day matching placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00205179
2003-0048, 5K23AG024302-03
Yes
Carey Gleaon, PhD, University of Wisconsin
University of Wisconsin, Madison
National Institutes of Health (NIH)
Principal Investigator: Carey E Gleason, PhD University of Wisconsin, Madison
University of Wisconsin, Madison
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP