Phase 3 Study of Combined Metabolic Activator Supplementation in Adults 50 and Older With Alzheimers Disease to Evaluate Safety and Effectiveness

What this Trial Is About

Researchers are evaluating metabolic improvements in people diagnosed with Alzheimers Disease through a dietary supplement called CMA2, which includes N-acetyl-L-cysteine, L-carnitine-L-tartrate, nicotinamide, and L-serine. This Phase 3, randomized, double-blinded, placebo-controlled study involves about 676 participants and is conducted at multiple clinical sites in Turkey. The study aims to understand how these supplements affect cognition and daily living activities in Alzheimers patients. Participants will be randomly assigned to take either CMA2 or a placebo twice daily for 26 weeks. The supplement is given as a soluble powder with a strawberry flavor, taken after breakfast and dinner. The first dose is given at the clinic with a two-hour observation for allergic reactions. Those who cannot tolerate the supplement will be withdrawn. The study includes four clinic visits screening, start of treatment, mid-treatment at 13 weeks, and end of treatment at 26 weeks. Monthly phone calls will check medication use, health status, and any side effects. During the study, participants will undergo tests including cognitive assessments ADAS-Cog, MMSE, daily living activity scales ADCS-ADL, and blood sample collections for advanced analyses. Optional samples of saliva, feces, and cerebrospinal fluid may be collected for further research. Researchers will monitor safety through various blood tests and vital signs. The main outcome measured is the change in cognitive function by the ADAS-Cog score over the 26 weeks.

Combined Metabolic Activator Supplementation in Subjects Diagnosed With Alzheimer's Disease