Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
72 participants
INTERVENTIONAL
2005-01-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Novasoy treated
100mg/day soy isoflavones
Novasoy
100mg/day soy isoflavones
Placebo
100mg/day matching placebo
Placebo
100mg/day matching placebo
Interventions
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Novasoy
100mg/day soy isoflavones
Placebo
100mg/day matching placebo
Eligibility Criteria
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Inclusion Criteria
* 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 (\<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
55 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute on Aging (NIA)
NIH
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Carey E Gleason, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin
Madison, Wisconsin, United States
Countries
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References
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Gleason CE, Carlsson CM, Barnet JH, Meade SA, Setchell KD, Atwood CS, Johnson SC, Ries ML, Asthana S. A preliminary study of the safety, feasibility and cognitive efficacy of soy isoflavone supplements in older men and women. Age Ageing. 2009 Jan;38(1):86-93. doi: 10.1093/ageing/afn227. Epub 2008 Dec 2.
Gleason CE, Fischer BL, Dowling NM, Setchell KD, Atwood CS, Carlsson CM, Asthana S. Cognitive Effects of Soy Isoflavones in Patients with Alzheimer's Disease. J Alzheimers Dis. 2015;47(4):1009-19. doi: 10.3233/JAD-142958.
Other Identifiers
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A534255
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/MEDICINE/MEDICINE*G
Identifier Type: OTHER
Identifier Source: secondary_id
2003-048
Identifier Type: -
Identifier Source: org_study_id
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