Combined Metabolic Activator Supplementation in Subjects Diagnosed With Alzheimer's Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
Combined metabolic activators: A total of 20g of CMA2 with strawberry aroma and colouring agent will be given. The IMP will be provided as a soluble powder packed as individual dosages in identical sachets. The powder should be dissolved in 200 ml preferably cold water before use. The powder can also be used on yoghurt or other food. The subjects will take two daily oral doses of the IMP, one dose just after breakfast and one dose just after dinner. Subjects who cannot tolerate (e.g., diarrhoea) taking full dose will be withdrawn from the study.
Collagen and maltodextrin: As placebo, a total of 20g of compound primarily containing collagen and maltodextrin will be administered. Placebo contains strawberry aroma flavouring and colouring agent.
Study summary
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.
Eligibility
Primary outcome measure(s)
- 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
Trial sites (8)
| Facility | City | Region | Status |
|---|---|---|---|
| Department of Neurology and Neuroscience, Faculty of Medicine, Alaaddin Keykubat University | Alanya | Turkey (Türkiye) | Recruiting |
| Ataturk University, Faculty of Medicine, Department of Neurology, Erzurum, Turkey; Movement Disorders and Neuromodulation Center, Ataturk University | Erzurum | Turkey (Türkiye) | Recruiting |
| Behavioural Neurology and Movement Disorders Unit, Department of Neurology, Istanbul Faculty of Medicine, Istanbul University | Istanbul | Turkey (Türkiye) | Recruiting |
| Haydarpaşa Numune Training and Research Hospital, University of Health Sciences Istanbul | Istanbul | Turkey (Türkiye) | Not Yet Recruiting |
| Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital, University of Health Sciences Istanbul | Istanbul | Turkey (Türkiye) | Recruiting |
| SB Haseki Training and Research Hospital, Istanbul, University of Health Sciences Istanbul | Istanbul | Turkey (Türkiye) | Recruiting |
| Sultan Abdülhamid Han Training and Research Hospital, University of Health Sciences Istanbul | Istanbul | Turkey (Türkiye) | Recruiting |
| Umraniye Training and Research Hospital, University of Health Sciences Istanbul | Istanbul | Turkey (Türkiye) | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07062198 on ClinicalTrials.gov ↗ ← All trials in Turkey