RecruitingPhase 3NCT07062198

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

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


Sponsor

ScandiBio Therapeutics AB

Enrollment

845 participants

Start Date

Sep 12, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of metabolic supplements — natural compounds that support energy production in cells — in people with Alzheimer's disease to see if they can help improve brain function and slow cognitive decline. **You may be eligible if...** - You are 50 years or older - You have been diagnosed with Alzheimer's disease and have a specific level of cognitive impairment on standardized tests (ADAS-Cog score of 12 or higher and GDS score of 4 or higher) - Your Alzheimer's treatment and symptoms have been stable for at least 1 month - If female, you are post-menopausal or have had a procedure (e.g., tubal ligation or hysterectomy) to prevent pregnancy **You may NOT be eligible if...** - You have had a stroke or serious brain injury recently - You have uncontrolled depression or other serious medical conditions - You or your legal representative cannot provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCombined 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.

OTHERCollagen 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)

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NCT07062198


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