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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00580931 |
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Date of registration:
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24/12/2007 |
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Primary sponsor: |
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Public title:
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Safety Study of Nicotinamide to Treat Alzheimer's Disease
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Scientific title:
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Efficacy of Nicotinamide for the Treatment of Alzheimer's Disease |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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50 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00580931 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Steven S Schreiber, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Regents of the University of California |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of probable AD according to DSM-IV criteria
- Mild to moderate dementia based on Mini-Mental State Examination [MMSE] score between
13-25
- Minimum age 50 years
- Brain imaging (computed tomographic scan or magnetic resonance image) within 12
months consistent with a diagnosis of probable AD
- Hachinski Ischemic Score of <4.
- Stable doses of concomitant medications, including cholinesterase inhibitors (ChEIs)
and/or memantine.
Exclusion Criteria:
- Dementia due to another cause
- Other neurological or psychiatric diseases
- Pseudodementia
- Unstable medical condition
- Initial treatment within 30 days of screening with a ChEI, memantine or any
investigational drug
- History of alcoholism, drug abuse, liver disease, peptic ulcer disease
- Pregnancy, or the potential to become pregnant.
Age minimum:
50 Years
Age maximum:
95 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Alzheimer's Disease
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Intervention(s)
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Drug: Enduramide placebo
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Drug: Nicotinamide
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Primary Outcome(s)
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Alzheimer's Disease Assessment Scale-Cognitive Subscale
[Time Frame: Baseline, 6 wk, 12 wk, 18 wk, 24 wk]
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Secondary ID(s)
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IIRG-07-61197
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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