Safety Study of Nicotinamide to Treat Alzheimer's Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Alzheimer's Association
Information provided by (Responsible Party):
Steven Schreiber, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00580931
First received: December 24, 2007
Last updated: December 11, 2013
Last verified: December 2013

December 24, 2007
December 11, 2013
January 2008
July 2014   (final data collection date for primary outcome measure)
Alzheimer's Disease Assessment Scale-Cognitive Subscale [ Time Frame: Baseline, 6 wk, 12 wk, 18 wk, 24 wk ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00580931 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety Study of Nicotinamide to Treat Alzheimer's Disease
Efficacy of Nicotinamide for the Treatment of Alzheimer's Disease

The purpose of this study is to determine whether nicotinamide, or vitamin B3, is safe and effective in the treatment of Alzheimer's disease.

The goal of this proposal is to show that, nicotinamide (NA), a B3 vitamin, is safe and effective for the treatment of patients with mild to moderate Alzheimer's disease (AD). NA is known to block the ability of certain proteins to regulate other proteins by removing their acetyl groups. Recent evidence has demonstrated that inhibitors such as NA prevent nerve cell degeneration in models of Huntington's disease (HD), Parkinson's disease and Lou Gehrig's disease (or ALS). Despite these beneficial effects in many different animal models, there have been no studies to date using these inhibitors in AD. In some of our recent studies we found that the potent inhibitor, NA, significantly improves learning and memory in transgenic mice that develop AD. NA treatment also resulted in striking changes in tau, a protein that abnormally accumulates in AD. NA has been extensively used in clinical studies over the last 40 years and is generally safe and well-tolerated. As NA is a safe and readily available vitamin supplement, our recent results provide a strong argument for a study of NA in patients with AD. We therefore propose to treat 50 patients with mild to moderate AD with either NA (1500 milligrams twice a day) or an identical but inactive drug (placebo) for 24 weeks. At 6 week intervals we will assess functions such as learning and memory, and ability to carry out daily activities as well as caregiver reports using standardized tests. We will also perform spinal taps at the beginning and end of the study to measure the level of abnormal tau protein in the cerebrospinal fluid. Blood tests will periodically be done to assess liver function and complete blood counts. The results of this study may provide the basis for a more extensive study of NA for the treatment of mild to moderate AD.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: Nicotinamide
    1500 mg twice a day for 6 months
    Other Name: Enduramide
  • Drug: Enduramide placebo
    1 tab twice a day
  • Experimental: 1
    Subjects will receive experimental drug in a blinded fashion.
    Intervention: Drug: Nicotinamide
  • Placebo Comparator: 2
    Identical in size, shape and color to experimental drug.
    Intervention: Drug: Enduramide placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
July 2014
July 2014   (final data collection date for primary outcome measure)

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.
Both
50 Years to 95 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00580931
IIRG-07-61197
No
Steven Schreiber, University of California, Irvine
University of California, Irvine
Alzheimer's Association
Principal Investigator: Steven S Schreiber, MD Regents of the University of California
University of California, Irvine
December 2013

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