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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Alzheimer Disease

In brief

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.

Key facts

Study ID: NCT07062198
Run by: ScandiBio Therapeutics AB
People needed: 845
Starts: 2025-09-12
Expected to finish: 2026-09-01
Last updated by the study team: 2026-02-06

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Men and women of non-childbearing potential ≥ 50 years of age.
Diagnosed with AD and at the Screening visit having the scores of ADAS-Cog ≥ 12 and GDS≥ 4.
Stable AD treatments and clinical course for at least 1 month.
Females of childbearing potential must have documented tubal ligation or hysterectomy; or be post-menopausal (defined as 12 months of amenorrhoea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) 25-140 IE/L and oestradiol <200 pmol/Lis confirmatory]).
Able to give written informed consent for participation in the study by the patient and/or legal representatives.

You may not qualify if…

History of stroke.
History of brain trauma < 14 days.
Uncontrolled diagnosed depression.
Uncontrolled (HbA1C > 8) type 1 or type 2 diabetes.
Severe swallowing problems.
PEG-feeding.
Chronic diarrhoea.
Chronic kidney disease with S-Creatinin > 1,30 mg/dl.
Active bronchial asthma at the time of screening.
History of phenylketonuria (contraindicated for NAC).
Known allergy for substances used in the study.
Known malignancies.
Use of dietary supplements such as vitamins, omega-3 products, or plant stanol/sterol products later than one (1) week prior to inclusion.
Use of anti-microbial agents later than one (1) week prior to inclusion.
Drug and/or alcohol abuse.
Subjects considered as inappropriate for this study for any reason (noncompliance etc.) per investigator assessment.
Administration of another new chemical entity (defined as a compound that has not been approved for marketing) or has participated in any other clinical study that included drug treatment with the last administration within 3 months prior to administration of IMP in this study.

Where it is running

Umraniye Training and Research Hospital, University of Health Sciences Istanbul — Istanbul, Turkey (Türkiye) (enrolling)
Ataturk University, Faculty of Medicine, Department of Neurology, Erzurum, Turkey; Movement Disorders and Neuromodulation Center, Ataturk University — Erzurum, Turkey (Türkiye) (enrolling)
Behavioural Neurology and Movement Disorders Unit, Department of Neurology, Istanbul Faculty of Medicine, Istanbul University — Istanbul, Turkey (Türkiye) (enrolling)
Department of Neurology and Neuroscience, Faculty of Medicine, Alaaddin Keykubat University — Alanya, Turkey (Türkiye) (enrolling)
Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital, University of Health Sciences Istanbul — Istanbul, Turkey (Türkiye) (enrolling)
SB Haseki Training and Research Hospital, Istanbul, University of Health Sciences Istanbul — Istanbul, Turkey (Türkiye) (enrolling)
Sultan Abdülhamid Han Training and Research Hospital, University of Health Sciences Istanbul — Istanbul, Turkey (Türkiye) (enrolling)
Haydarpaşa Numune Training and Research Hospital, University of Health Sciences Istanbul — Istanbul, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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