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NEAT (Nicotinamide as an Early Alzheimer's Disease Treatment) Study

Purpose

The NEAT study is a phase IIb clinical trial sponsored by a University of California Cures for Alzheimer’s Initiative grant, focusing on nicotinamide, a soluble form of vitamin B3. This 12-month study will investigate the safety and tolerability of daily high dose oral nicotinamide, and assess whether nicotinamide is able to reduce levels of phosphorylated tau found in spinal fluid. It will also assess whether nicotinamide is effective in reducing the rate of cognitive and functional decline. This study is for individuals aged 50-85 with a diagnosis of mild cognitive impairment or mild dementia due to Alzheimer’s disease. Participants will have a 50% chance of receiving the study drug vs placebo (an inactive substance). To learn more, please call Celine Ossinalde at (310) 794-6191 or send an email to: This email address is being protected from spambots. You need JavaScript enabled to view it..

Sponsor: University of California, Irvine
ClinicalTrials.gov Identifier: NCT03061474

Condition: Intervention: Phase:
Alzheimer's Disease
Mild Cognitive Impairment
Drug: Nicotinamide
Drug: Placebo Comparator
Phase II

Study Type: Interventional
Study Design: Allocation: A Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigato
Masking Description: Double-Blind-Randomized
Primary Purpose: Treatment
Official Title: A Double-Blind-Randomized, Placebo-Controlled Adaptive Design Trial of Nicotinamide in Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease Dementia
Length of Study: 12 months
Eligibility
Ages Eligible for Study: 50 Years and older
Genders Eligible for Study: Both
Criteria

Inclusion Criteria:

Mild Cognitive Impairment (MCI) or dementia due to Alzheimer's disease (AD)
Biomarker criteria: Cerebral Spinal Fluid (CSF) Amyloid Beta 1-42 (Aβ42) <= 200 pg/mL, or A ratio of total tau to Aβ42 >= 0.39, or A ratio of p-tau181to Aβ42 >= 0.14.
Mini-Mental State Exam (MMSE) >= 20
Blood laboratories, urinalysis, and electrocardiogram are within normal limits or deemed clinically not significant by the site investigator.
Stable medications (including approved AD therapies) for at least 4 weeks
At least 6 years of education
Able to swallow oral tablets
Speaks English fluently
Available qualified study partner (>=3 times per week in-person communication with the participant)

Exclusion Criteria:

Active neurological or psychiatric diagnosis other than AD that may affect cognition and/or function. (Obstructive sleep apnea is permitted, if treated.)
Inability to undergo lumbar puncture, including use of Coumadin, novel oral anticoagulants, clopidogrel, or dipyridamole. Use of aspirin <= 325mg daily is permitted.
Hachinski ischemic scale > 4
Magnetic Resonance Imaging (MRI) incompatibility
MRI evidence of cortical stroke >1cm, superficial siderosis, or extensive white matter hyperintensity (Cardiovascular Health Study score 7-8+)
Diagnosis of cancer in the previous 5 years (with the exception of basal or squamous cell carcinoma)
Geriatric Depression Scale (GDS) score > 6
History within the past 5 years of alcohol or substance use disorder
Laboratory evidence of a clinically significant abnormality that may interfere with study assessments
Active partial or total malabsorptive disease (e.g., celiac disease)
Resides in a skilled nursing facility
Participation in a clinical trial of a potential disease-modifying therapy for AD in previous 6-months (time between last investigational drug administration and baseline for the current study)
Pregnant, lactating or of child bearing potential (that is, women must be 2 years post-menopausal or surgically sterile to be considered not child bearing potential).
Unwillingness to abstain from over-the-counter nicotinamide for the duration of the trial

Contact: Celine Ossinalde at (310) 794-6191 or This email address is being protected from spambots. You need JavaScript enabled to view it. to participate in this study or for more information.