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

Korábbi kezelés

• 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.

Más betegség

• 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.

Laborértékek

• Uncontrolled (HbA1C > 8) type 1 or type 2 diabetes.
• Chronic kidney disease with S-Creatinin > 1,30 mg/dl.

Egyéb

• 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.

• 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.