NCT07062198RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 6 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 845 (estimated)
- First submitted
- 11 Jun 2025
- Start date
- 12 Sept 2025
- Primary completion date
- Sept 2026
- Lead sponsor
- ScandiBio Therapeutics AB
- Diseases
- Alzheimer disease
- NCT number
- NCT07062198
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 845
- From 12 Sept 2025 to the primary completion date, Sept 2026
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- History of stroke.
- History of brain trauma \< 14 days.
- History of phenylketonuria (contraindicated for NAC).
- Known allergy for substances used in the study.
- Known malignancies.
Lab values
- Uncontrolled (HbA1C \> 8) type 1 or type 2 diabetes.
- Chronic kidney disease with S-Creatinin \> 1,30 mg/dl.
Other
- Uncontrolled diagnosed depression.
- Severe swallowing problems.
- PEG-feeding.
- Chronic diarrhoea.
- Active bronchial asthma at the time of screening.
- Subjects considered as inappropriate for this study for any reason (noncompliance etc.) per investigator assessment.
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Neurology and Neuroscience, Faculty of Medicine, Alaaddin Keykubat University Coordinator of this site? Confirm its status | Alanya | Turkey (Türkiye) | Recruiting |
| Ataturk University, Faculty of Medicine, Department of Neurology, Erzurum, Turkey; Movement Disorders and Neuromodulation Center, Ataturk University Coordinator of this site? Confirm its status | Erzurum | Turkey (Türkiye) | Recruiting |
| Haydarpaşa Numune Training and Research Hospital, University of Health Sciences Istanbul Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Not yet recruiting |
| Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital, University of Health Sciences Istanbul Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| Umraniye Training and Research Hospital, University of Health Sciences Istanbul Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| SB Haseki Training and Research Hospital, Istanbul, University of Health Sciences Istanbul Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| Behavioural Neurology and Movement Disorders Unit, Department of Neurology, Istanbul Faculty of Medicine, Istanbul University Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| Sultan Abdülhamid Han Training and Research Hospital, University of Health Sciences Istanbul Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.