Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Phase 3

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

NCT07062198 · tracked via the Priya Life Science Turkey tracker
Sponsor
ScandiBio Therapeutics AB
Phase
Phase 3
Started
2025-09-12
Last updated
2026-02-06

Condition(s) studied

Alzheimer Disease

Investigational drug(s) / intervention(s)

Combined metabolic activatorsCollagen and maltodextrin

Combined metabolic activators: A total of 20g of CMA2 with strawberry aroma and colouring agent will be given. The IMP will be provided as a soluble powder packed as individual dosages in identical sachets. The powder should be dissolved in 200 ml preferably cold water before use. The powder can also be used on yoghurt or other food. The subjects will take two daily oral doses of the IMP, one dose just after breakfast and one dose just after dinner. Subjects who cannot tolerate (e.g., diarrhoea) taking full dose will be withdrawn from the study.

Collagen and maltodextrin: As placebo, a total of 20g of compound primarily containing collagen and maltodextrin will be administered. Placebo contains strawberry aroma flavouring and colouring agent.

Study 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

Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score from baseline to end-of-treatment — Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
    The test administrator adds up points for the errors in each task for a total score ranging from 0 to 70. The greater the dysfunction, the greater the score. A score of 70 represents the most severe impairment and 0 represents the least impairment

Trial sites (8)

FacilityCityRegionStatus
Department of Neurology and Neuroscience, Faculty of Medicine, Alaaddin Keykubat University Alanya Turkey (Türkiye) Recruiting
Ataturk University, Faculty of Medicine, Department of Neurology, Erzurum, Turkey; Movement Disorders and Neuromodulation Center, Ataturk University Erzurum Turkey (Türkiye) Recruiting
Behavioural Neurology and Movement Disorders Unit, Department of Neurology, Istanbul Faculty of Medicine, Istanbul University Istanbul Turkey (Türkiye) Recruiting
Haydarpaşa Numune Training and Research Hospital, University of Health Sciences Istanbul Istanbul Turkey (Türkiye) Not Yet Recruiting
Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital, University of Health Sciences Istanbul Istanbul Turkey (Türkiye) Recruiting
SB Haseki Training and Research Hospital, Istanbul, University of Health Sciences Istanbul Istanbul Turkey (Türkiye) Recruiting
Sultan Abdülhamid Han Training and Research Hospital, University of Health Sciences Istanbul Istanbul Turkey (Türkiye) Recruiting
Umraniye Training and Research Hospital, University of Health Sciences Istanbul Istanbul Turkey (Türkiye) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07062198 on ClinicalTrials.gov ↗ ← All trials in Turkey