Alzheimer's Disease: Potential Benefit of Isoflavones

This study is currently recruiting participants.

Verified by University of Wisconsin, Madison, November 2008

Sponsors and Collaborators:	University of Wisconsin, Madison National Institutes of Health (NIH)
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00205179

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 II

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title:	Alzheimer's Disease: Potential Benefit of Isoflavones

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
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active: Experimental 100mg/day soy isoflavones	Drug: Novasoy 100mg/day soy isoflavones
Placebo: Placebo Comparator 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205179

Contacts

Contact: Kirsten Walth

866-636-7764

memory-research@medicine.wisc.edu

Locations

United States, Wisconsin
University of Wisconsin	Recruiting
Madison, Wisconsin, United States, 53792
Contact: Kirsten Walth 866-636-7764 memory-research@medicine.wisc.edu

Sponsors and Collaborators

University of Wisconsin, Madison

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Carey E Gleason, PhD

University of Wisconsin, Madison

More Information

Responsible Party:	University of Wisconsin ( Carey Gleaon, PhD )
Study ID Numbers:	2003-0048, 5K23AG024302-03
Study First Received:	September 13, 2005
Last Updated:	November 8, 2008
ClinicalTrials.gov Identifier:	NCT00205179
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases

Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on January 16, 2009