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
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Turkey
Department of Neurology and Neuroscience, Faculty of Medicine, Alaaddin Keykubat University
NOT_YET_RECRUITING
Alanya
Ataturk University, Faculty of Medicine, Department of Neurology, Erzurum, Turkey; Movement Disorders and Neuromodulation Center, Ataturk University
RECRUITING
Erzurum
Behavioural Neurology and Movement Disorders Unit, Department of Neurology, Istanbul Faculty of Medicine, Istanbul University
RECRUITING
Istanbul
Department of Neurology, School of Medicine, Koc University
NOT_YET_RECRUITING
Istanbul
Haydarpaşa Numune Training and Research Hospital, University of Health Sciences Istanbul
NOT_YET_RECRUITING
Istanbul
Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital, University of Health Sciences Istanbul
NOT_YET_RECRUITING
Istanbul
SB Haseki Training and Research Hospital, Istanbul, University of Health Sciences Istanbul
RECRUITING
Istanbul
Sultan Abdülhamid Han Training and Research Hospital, University of Health Sciences Istanbul
RECRUITING
Istanbul
Umraniye Training and Research Hospital, University of Health Sciences Istanbul