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

NCT07062198 | Recruiting Phase 3 DMC

• 1 other identifier: SB-AD-002
• Study Type: interventional
• Target: 845
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Change in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score from baseline to end-of-treatment

  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

  Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)

Secondary Outcomes (23)

• Change in Mini Mental State Examination (MMSE) score from baseline to end-of-treatment

  Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)

• Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) score from baseline to end-of-treatment

  Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)

• To evaluate compliance daily two doses treatment in patients

  Visit 5 (13 weeks), Visit 8 (26 weeks)

• Change in body weight from baseline through-out the study

  Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)

• Change in body height from baseline through-out the study

  Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Drug: Combined metabolic activators

Placebo Arm

PLACEBO COMPARATOR

Other: Collagen and maltodextrin

Interventions

Combined metabolic activators DRUG

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.

Treatment Arm

Collagen and maltodextrin OTHER

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

Placebo Arm

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• ScandiBio Therapeutics AB: lead

Study Sites (8)

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

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Collagen; maltodextrin

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biopolymers; Polymers; Macromolecular Substances; Extracellular Matrix Proteins; Scleroproteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Sevki SAHIN, Prof. Dr.

  Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital, University of Health Sciences Istanbul 34766, Turkiye

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sevki SAHIN, Prof. Dr.

CONTACT

+90 216 606 33 00; drsahin@gmail.com

Ozlem Totuk, Dr.

CONTACT

+90 216 606 33 00; totukozlem@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: July 14, 2025
• Study Start: September 12, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (8)