Actively Recruiting

Phase 3
Age: 50Years +
All Genders
NCT07062198

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

Led by ScandiBio Therapeutics AB · Updated on 2026-02-06

845

Participants Needed

8

Research Sites

50 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  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.
Not Eligible

You will not qualify if you...

  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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

Department of Neurology and Neuroscience, Faculty of Medicine, Alaaddin Keykubat University

Alanya, Turkey (Türkiye)

Actively Recruiting

2

Ataturk University, Faculty of Medicine, Department of Neurology, Erzurum, Turkey; Movement Disorders and Neuromodulation Center, Ataturk University

Erzurum, Turkey (Türkiye)

Actively Recruiting

3

Behavioural Neurology and Movement Disorders Unit, Department of Neurology, Istanbul Faculty of Medicine, Istanbul University

Istanbul, Turkey (Türkiye)

Actively Recruiting

4

Haydarpaşa Numune Training and Research Hospital, University of Health Sciences Istanbul

Istanbul, Turkey (Türkiye)

Not Yet Recruiting

5

Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital, University of Health Sciences Istanbul

Istanbul, Turkey (Türkiye)

Actively Recruiting

6

SB Haseki Training and Research Hospital, Istanbul, University of Health Sciences Istanbul

Istanbul, Turkey (Türkiye)

Actively Recruiting

7

Sultan Abdülhamid Han Training and Research Hospital, University of Health Sciences Istanbul

Istanbul, Turkey (Türkiye)

Actively Recruiting

8

Umraniye Training and Research Hospital, University of Health Sciences Istanbul

Istanbul, Turkey (Türkiye)

Actively Recruiting

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Research Team

S

Sevki SAHIN, Prof. Dr.

CONTACT

O

Ozlem Totuk, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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