Safety Study of Nicotinamide to Treat Alzheimer's Disease

NCT00580931 | Completed Phase 1

• 1 other identifier: IIRG-07-61197
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer's Disease

Keywords

nutraceutical, dementia, cognition, HDAC inhibitor

Outcome Measures

Primary Outcomes (1)

• Alzheimer's Disease Assessment Scale-Cognitive Subscale

  Baseline, 6 wk, 12 wk, 18 wk, 24 wk

Study Arms (2)

1

EXPERIMENTAL

Subjects will receive experimental drug in a blinded fashion.

Drug: Nicotinamide

2

PLACEBO COMPARATOR

Identical in size, shape and color to experimental drug.

Drug: Enduramide placebo

Interventions

Nicotinamide DRUG

1500 mg twice a day for 6 months

Also known as: Enduramide

1

Enduramide placebo DRUG

1 tab twice a day

2

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead
• Alzheimer's Association: collaborator

Study Sites (1)

UC Irvine School of Medicine

Irvine, California, 92697, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Interventions

Niacinamide

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Steven S Schreiber, MD

  Regents of the University of California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: December 24, 2007
• First Posted: December 27, 2007
• Study Start: January 1, 2008
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: January 25, 2017

Record last verified: 2017-01

Locations

US (1)