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

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 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.

Conditions2

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