A Phase 2, Proof-of-Concept, Double-Blind-Randomized, Placebo-Controlled Adaptive Design Trial of Nicotinamide in MCI due to AD and Mild AD Dementia

The NEAT study is a clinical trial sponsored by the University of California Cures for Alzheimer’s Initiative grant, focusing on nicotinamide, a dissolving form of vitamin B3. It is taking place at two University of California Alzheimer’s research centers (UCLA & UC Irvine).

The 12-month study is investigating the safety and tolerability of a daily high dose of oral nicotinamide, determining if it can reduce levels of tau found in spinal fluid. Tau is one of the brain proteins associated with Alzheimer’s disease.

The study also measures whether nicotinamide is effective in reducing cognitive decline. This study is for individuals already diagnosed with mild cognitive impairment or mild dementia due to Alzheimer’s disease. Other requirements also apply. Participants will have a 50 percent chance of receiving the study drug or an inactive substance known as a placebo.

The NEAT Study is enrolling adults ages 50 and older who:

  • Are experiencing memory loss or mild Alzheimer’s disease
  • Are in good health otherwise to participate in the study
  • Are willing to take B3 vitamins (nicotinamide) daily

What would be expected of me if I enroll in the NEAT study?

After completing a variety of tests during the screening phase, eligible adults will enroll in the NEAT study and be randomly assigned to either an active therapy group (daily B3 vitamin use) or to a placebo (no treatment group).

 

Participants will have to take assigned treatment twice daily for one year. Those enrolled will have to come in clinic for some follow up at start of study drug, 3 months, 6 months and 12 months. Participants will be required to complete a lumbar puncture and MRI brain scan at screening and at the end of study. In clinic visits may include routine blood work as well.

How do I enroll?

There are two medical centers in Southern California participating in the NEAT Study. Please refer to your nearest site location in order to learn more about enrolling in the study.

Who is Eligible to Participate?

We are looking for people who:

  • Are experiencing memory loss or mild Alzheimer’s disease
  • Are age 50 and older
  • Are willing to be assigned to either an active therapy group (daily B3 vitamin use) or to a placebo for the duration of the 12-month study
  • Are able to swallow oral tablets
  • Are willing and able to travel to the medical center approximately four times a year for the duration of the study
  • Are willing to participate in physical exams, blood collection, cognitive testing, brain imaging, and lumbar punctures at the medical center
  • Speak English fluently
  • Are in overall good general health with no planned surgeries over the next 18 months that could interfere with study participation
  • Have a close friend or family member with whom the participant has regular weekly contact, who can serve as a study partner and accompany the participant to many clinic visits

The NEAT Study Site Locations

 

University of California Los Angeles

Mary S. Eaton Center for Alzheimer’s Disease Research, UCLA

710 Westwood Plaza, Room 1123

Los Angeles, CA 90095

Contact: Celine Ossinalde

Phone: (310) 794-6191

Email: cossinalde@mednet.ucla.edu

 

University of California, Irvine

Memory Assessment and Research Center, UCI

1100 Gottschalk Medical Plaza

Irvine, CA 92697-4285

Contact: Beatriz Yanez

Phone: (949) 824-3250

Email: byanez@uci.edu