Status:
COMPLETED
Randomized Trial of a Nutritional Supplement in Alzheimer's Disease
Lead Sponsor:
US Department of Veterans Affairs
Collaborating Sponsors:
Alzheimer's Association
Icahn School of Medicine at Mount Sinai
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-90 years
Phase:
PHASE3
Brief Summary
Alzheimer's disease (AD), one of the leading causes of morbidity and mortality in the elderly is characterized by progressive cognitive decline and certain neuropathological features. Currently, ther...
Detailed Description
Subjects will be assessed by their capacity to consent by a psychiatrist independent of this study. Subjects who are determined to have capacity will sign consent. For subjects determined to lack capa...
Eligibility Criteria
Inclusion
- Consenting individuals as defined by IRB guidelines
- NINCDS/ADRDA criteria for probable AD
- Community dwelling
- Age: greater than or equal to 50 years
- MMSE between 12 and 26, inclusive
- Stable medical condition for 3 months prior to screening visit
- Stable doses of (non excluded) medications with central nervous system activity for 4 weeks prior to the screening visit (For cholinesterase inhibitors there should be no plan of dose escalation)
- Physically acceptable for this study as confirmed by medical history, physical exam, neurologic exam and clinical laboratory tests
- Supervision available for administration of study medications
- Study partner to accompany subject to all scheduled visits and complete informant-based assessments.
- Fluent in English or Spanish
- Modified Hachinski \< 4
- CT or MRI since onset of memory impairment demonstrating absence of clinically significant focal lesion (One lacune in a non-critical brain region is acceptable)
- Able to complete baseline assessments
- 6 years of education, or work history sufficient to exclude mental retardation
- Able to ingest oral medication
Exclusion
- Active liver disease or persistent elevation in serum transaminase
- Severe renal disease
- \- Hx of diabetes mellitus (both insulin-dependent and non-insulin-dependent) or blood glucose \>150 mg/dl
- Active neoplastic disease (skin tumors other than melanoma are not exclusionary; subjects with stable prostate cancer or other stable cancers may be included at the discretion of the PI (Sano))
- Use of another investigational agent within 2 months of the screening visit
- History of clinically significant stroke
- Current evidence or history in the past 2 years of seizures, head injury with loss of consciousness and/or immediate confusion after the injury
- Current DSM-IV criteria-based diagnosis for major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse.
- Blindness, deafness, language difficulties or any other disability which may interfere with testing ability
- In female subjects, no history of menopause
- Use of medications containing aluminum hydroxide, including anti-ulcer antacids such as Alternagel, Amphojel, Alu-tab, Maalox and Mylanta
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00678431
Start Date
January 1 2008
End Date
June 1 2011
Last Update
November 15 2012
Active Locations (1)
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1
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, United States, 10468