A Phase 3, Randomised, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy, Tolerability, and Safety of Combined Metabolic Activator Supplementation in Subjects Diagnosed With Alzheimer's Disease (COGNIS)

NCT07062198 Phase 3 RECRUITING

This randomised, double-blinded, placebo-controlled study aims to establish metabolic improvements in subjects diagnosed with Alzheimer's Disease (AD) by treatment with CMA2 including N-acetyl-L-cysteine (NAC), L-carnitine-L-tartrate (LCAT), nicotinamide (niacinamide), and L-serine. Participants will take the drug CMA2 or a placebo twice a day for 26 weeks. They will visit the clinic 4 times for checkups and tests.

Details

Lead sponsor	ScandiBio Therapeutics AB
Phase	Phase 3
Status	RECRUITING
Enrolment	845
Start date	2025-09-12
Completion	2026-09

Conditions

• Alzheimer Disease

Interventions

• Combined metabolic activators
• Collagen and maltodextrin

Primary outcomes

• Change in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score from baseline to end-of-treatment — Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
  The test administrator adds up points for the errors in each task for a total score ranging from 0 to 70. The greater the dysfunction, the greater the score. A score of 70 represents the most severe impairment and 0 represents the least impairment

Countries

Turkey (Türkiye)