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
ScandiBio Therapeutics AB
845 participants
Sep 12, 2025
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
Inclusion Criteria5
- 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.
Exclusion Criteria17
- 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.
Interventions
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.
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07062198