Combined Metabolic Activator Supplementation in Subjects Diagnosed With Alzheimer's Disease
Recruiting · NCT07062198 · Interventional (participants receive a specific treatment) · Lead sponsor: ScandiBio Therapeutics AB
View the official record on ClinicalTrials.gov →Interventions studied
Collagen and maltodextrinCombined metabolic activators
What this trial is about
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.
Who can take part
Age range
50 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
8 locations listed.
- Department of Neurology and Neuroscience, Faculty of Medicine, Alaaddin Keykubat University - Alanya, Turkey (Türkiye)
- Ataturk University, Faculty of Medicine, Department of Neurology, Erzurum, Turkey; Movement Disorders and Neuromodulation Center, Ataturk University - Erzurum, Turkey (Türkiye)
- Behavioural Neurology and Movement Disorders Unit, Department of Neurology, Istanbul Faculty of Medicine, Istanbul University - Istanbul, Turkey (Türkiye)
- Haydarpaşa Numune Training and Research Hospital, University of Health Sciences Istanbul - Istanbul, Turkey (Türkiye)
- Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital, University of Health Sciences Istanbul - Istanbul, Turkey (Türkiye)
- SB Haseki Training and Research Hospital, Istanbul, University of Health Sciences Istanbul - Istanbul, Turkey (Türkiye)
- Sultan Abdülhamid Han Training and Research Hospital, University of Health Sciences Istanbul - Istanbul, Turkey (Türkiye)
- Umraniye Training and Research Hospital, University of Health Sciences Istanbul - Istanbul, Turkey (Türkiye)