NCT07062198 · Phase 3 · RECRUITING
Combined Metabolic Activator Supplementation in Subjects Diagnosed With Alzheimer's Disease
This trial tests whether a combination of four supplement-type compounds (NAC, L-carnitine tartrate, nicotinamide, and L-serine) improves metabolic markers in people already diagnosed with Alzheimer's. Participants take it or a placebo twice a day for 26 weeks. It is a Phase 3 trial, a larger step to check whether it works and is safe, not yet proven or approved.
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're excluded 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-02-06