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Combined Metabolic Activator Supplementation in Subjects Diagnosed With Alzheimer's Disease
Sponsor: ScandiBio Therapeutics AB
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.
Official title: 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
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
845
Start Date
2025-09-12
Completion Date
2026-09
Last Updated
2026-02-06
Healthy Volunteers
No
Conditions
Interventions
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 Subjects who cannot tolerate (e.g., diarrhoea) taking full dose will be withdrawn from the study.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.
Locations (8)
Department of Neurology and Neuroscience, Faculty of Medicine, Alaaddin Keykubat University
Alanya, Turkey (Türkiye)
Ataturk University, Faculty of Medicine, Department of Neurology, Erzurum, Turkey; Movement Disorders and Neuromodulation Center, Ataturk University
Erzurum, Turkey (Türkiye)
Behavioural Neurology and Movement Disorders Unit, Department of Neurology, Istanbul Faculty of Medicine, Istanbul University
Istanbul, Turkey (Türkiye)
Haydarpaşa Numune Training and Research Hospital, University of Health Sciences Istanbul
Istanbul, Turkey (Türkiye)
Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital, University of Health Sciences Istanbul
Istanbul, Turkey (Türkiye)
SB Haseki Training and Research Hospital, Istanbul, University of Health Sciences Istanbul
Istanbul, Turkey (Türkiye)
Sultan Abdülhamid Han Training and Research Hospital, University of Health Sciences Istanbul
Istanbul, Turkey (Türkiye)
Umraniye Training and Research Hospital, University of Health Sciences Istanbul
Istanbul, Turkey (Türkiye)