Recruiting

COGNISMetabolic Activator Supplementation for Alzheimer's Disease

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Study Aim

This phase 3 clinical trial is studying if a metabolic activator supplement can improve cognitive function in adults with Alzheimer's disease. The main goal is to see if it can help slow down memory loss and cognitive decline, as measured by the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) test.

What is being tested

Combined metabolic activators

+ Collagen and maltodextrin

DrugOther
Who is being recruted

Alzheimer Disease+6

+ Mental Disorders

+ Brain Diseases

Over 50 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Placebo-ControlledPhase 3
Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorScandiBio Therapeutics AB
Study ContactSevki SAHIN, Prof. Dr.More contacts
Last updated: February 7, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 12, 2025

Actual date on which the first participant was enrolled.

This clinical trial aims to investigate whether a dietary supplement called CMA2 can help improve the metabolism of people diagnosed with Alzheimer's Disease. Alzheimer's affects memory and cognitive functions, and this study seeks to see if CMA2, which includes ingredients like NAC, LCAT, niacinamide, and L-serine, can positively impact these areas. This research is significant as it may offer a new way to support those living with Alzheimer's, potentially improving their quality of life. Participants in the study will be randomly assigned to receive either the CMA2 supplement or a placebo for 26 weeks, taking it twice a day by mouth. They will attend four clinical visits over this period, with additional check-ins via phone. The study will measure the effects of the supplement on mental function and daily life activities using specific cognitive tests. Blood samples will also be taken to analyze various biological markers. Optional tests, such as saliva and feces sampling, may be conducted to explore the effects further. Participants will be closely monitored for any adverse reactions, especially after the first dose, to ensure safety.

Official TitleA 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
NCT07062198
Principal SponsorScandiBio Therapeutics AB
Study ContactSevki SAHIN, Prof. Dr.More contacts
Last updated: February 7, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

845 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Alzheimer DiseaseMental DisordersBrain DiseasesCentral Nervous System DiseasesDementiaNervous System DiseasesNeurodegenerative DiseasesNeurocognitive DisordersTauopathies

Criteria

4 inclusion criteria required to participate
Able to give written informed consent for participation in the study by the patient and/or legal representatives.
Diagnosed with AD and at the Screening visit having the scores of ADAS-Cog ≥ 12 and GDS≥ 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]).
Stable AD treatments and clinical course for at least 1 month.
11 exclusion criteria prevent from participating
Drug and/or alcohol abuse.
Use of anti-microbial agents later than one (1) week prior to inclusion.
Uncontrolled diagnosed depression.
PEG-feeding.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

Recruiting

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

Alanya, Turkey (Türkiye)Open Department of Neurology and Neuroscience, Faculty of Medicine, Alaaddin Keykubat University in Google Maps
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

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

Istanbul, Turkey (Türkiye)
Recruiting
8 Study Centers