Combined metabolic supplements for people 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

This test will see if taking CMA2 (a mix of N‑acetyl‑L‑cysteine, L‑carnitine‑L‑tartrate, niacinamide, and L‑serine) twice daily for 26 weeks helps metabolism and thinking in people aged 50 and older with Alzheimer's disease.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 845 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: ScandiBio Therapeutics AB (industry)
• Locations: 8 sites (Alanya and 7 other locations)
• Trial ID: NCT07062198 on ClinicalTrials.gov

What this trial studies

This is a randomized, double‑blind, placebo‑controlled Phase 3 study conducted at multiple centers in Turkey that will randomize up to 845 participants to receive either CMA2 or placebo twice daily for 26 weeks. Participants will attend four in‑person clinic visits (screening, baseline/first dose, week 13, and week 26) with monthly phone contacts for compliance and safety checks, and will be observed for two hours after the first dose. Cognitive and daily function outcomes will be measured using MMSE, ADAS‑Cog, and ADCS‑ADL, and blood samples will be collected to measure metabolic changes. The trial targets about 676 evaluable subjects and follows specific inclusion and exclusion criteria to ensure participant safety.

Who should consider this trial

Good fit: Ideal candidates are adults aged 50 or older with a diagnosis of Alzheimer's disease who meet thresholds on cognitive scales (ADAS‑Cog ≥ 12 and GDS ≥ 4), are on stable AD treatments, can consent, and are non‑childbearing or surgically/postmenopausal women.

Not a fit: People with recent stroke or recent brain trauma, uncontrolled depression or poorly controlled diabetes (HbA1c > 8), severe swallowing problems or PEG feeding, chronic diarrhea, significant kidney impairment (serum creatinine > 1.30 mg/dL), active uncontrolled asthma, or other exclusion conditions are not eligible and are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, CMA2 could improve metabolic markers and translate into better cognitive performance or daily functioning for people with Alzheimer's disease.

How similar studies have performed: Individual components like NAC, carnitine, niacinamide, and serine have shown mixed signals in smaller studies, but this combined CMA2 approach is being tested in a larger, confirmatory Phase 3 setting.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. History of stroke.
2. History of brain trauma \< 14 days.
3. Uncontrolled diagnosed depression.
4. Uncontrolled (HbA1C \> 8) type 1 or type 2 diabetes.
5. Severe swallowing problems.
6. PEG-feeding.
7. Chronic diarrhoea.
8. Chronic kidney disease with S-Creatinin \> 1,30 mg/dl.
9. Active bronchial asthma at the time of screening.
10. History of phenylketonuria (contraindicated for NAC).
11. Known allergy for substances used in the study.
12. Known malignancies.
13. Use of dietary supplements such as vitamins, omega-3 products, or plant stanol/sterol products later than one (1) week prior to inclusion.
14. Use of anti-microbial agents later than one (1) week prior to inclusion.
15. Drug and/or alcohol abuse.
16. Subjects considered as inappropriate for this study for any reason (noncompliance etc.) per investigator assessment.
17. 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 this trial is running

Alanya and 7 other locations

• 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)

Study contacts

• Principal investigator: Sevki SAHIN, Prof. Dr. — Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital, University of Health Sciences Istanbul 34766, Turkiye
• Study coordinator: Sevki SAHIN, Prof. Dr.

Conditions: Alzheimer Disease