Safety Study of Nicotinamide to Treat Alzheimer's Disease
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00580931 |
Recruitment Status
:
Completed
First Posted
: December 27, 2007
Last Update Posted
: January 25, 2017
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer's Disease | Drug: Nicotinamide Drug: Enduramide placebo | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Efficacy of Nicotinamide for the Treatment of Alzheimer's Disease |
Actual Study Start Date : | January 2008 |
Actual Primary Completion Date : | July 2014 |
Actual Study Completion Date : | July 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Subjects will receive experimental drug in a blinded fashion.
|
Drug: Nicotinamide
1500 mg twice a day for 6 months
Other Name: Enduramide
|
Placebo Comparator: 2
Identical in size, shape and color to experimental drug.
|
Drug: Enduramide placebo
1 tab twice a day
|
- Alzheimer's Disease Assessment Scale-Cognitive Subscale [ Time Frame: Baseline, 6 wk, 12 wk, 18 wk, 24 wk ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years to 95 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00580931
United States, California | |
UC Irvine School of Medicine | |
Irvine, California, United States, 92697 |
Principal Investigator: | Steven S Schreiber, MD | Regents of the University of California |
Responsible Party: | Steven Schreiber, Professor of Neurology, University of California, Irvine |
ClinicalTrials.gov Identifier: | NCT00580931 History of Changes |
Other Study ID Numbers: |
IIRG-07-61197 |
First Posted: | December 27, 2007 Key Record Dates |
Last Update Posted: | January 25, 2017 |
Last Verified: | January 2017 |
Keywords provided by Steven Schreiber, University of California, Irvine:
nutraceutical, dementia, cognition, HDAC inhibitor |
Additional relevant MeSH terms:
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Niacinamide Niacin |
Nicotinic Acids Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Vasodilator Agents |