Alzheimer DiseasePhase 3COGNISNCT07062198
Combined Metabolic Activator Supplementation in Subjects Diagnosed With Alzheimer's Disease
A Phase 3 study testing Combined metabolic activators and Collagen and maltodextrin in people with Alzheimer Disease, run by ScandiBio Therapeutics AB at 8 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Combined metabolic activators and Collagen and maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 845 participants
- Where
- 8 sitesTurkey (Türkiye)
- Study dates
- 12 Sep 2025to Sep 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Turkey (Türkiye)8 sites, 8 recruiting
- Recruiting
Department of Neurology and Neuroscience, Faculty of Medicine, Alaaddin Keykubat University
Alanya
Burak Yuluğ, Dr.
Burak Yuluğ, Dr.
- Recruiting
Ataturk University, Faculty of Medicine, Department of Neurology, Erzurum, Turkey; Movement Disorders and Neuromodulation Center, Ataturk University
Erzurum
Mustafa Ceylan, Assoc. Prof. Dr.
Mustafa Ceylan, Assoc. Prof. Dr.
- Recruiting
Behavioural Neurology and Movement Disorders Unit, Department of Neurology, Istanbul Faculty of Medicine, Istanbul University
Istanbul
Haşmet Hanagasi, Prof. Dr.
Haşmet Hanagasi, Prof. Dr.
- Not yet recruiting
Haydarpaşa Numune Training and Research Hospital, University of Health Sciences Istanbul
Istanbul
Gülbün Asuman Yüksel, Dr.
Gülbün Asuman Yüksel, Dr.
- Recruiting
Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital, University of Health Sciences Istanbul
Istanbul
Şevki Şahin, Prof. Dr.
Şevki Şahin, Prof. Dr.
- Recruiting
SB Haseki Training and Research Hospital, Istanbul, University of Health Sciences Istanbul
Istanbul
Ayla Çulha Oktar, Dr.
Ayla Çulha Oktar, Dr.
- Recruiting
Sultan Abdülhamid Han Training and Research Hospital, University of Health Sciences Istanbul
Istanbul
Nazlı Gamze Bülbül, Dr.
Nazlı Gamze Bülbül, Dr.
- Recruiting
Umraniye Training and Research Hospital, University of Health Sciences Istanbul
Istanbul
Nevin Pazarcı, Dr.
Nevin Pazarcı, Dr.
About this study
Official title: A 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
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.
Read the detailed description
This will be a randomised, double-blinded, placebo-controlled, multi-centre Phase 3 study with the aim to establish metabolic improvements in subjects diagnosed with AD by dietary supplementation with CMA2, including NAC, LCAT, niacinamide, and L-serine. The study will be performed at approximately 9 clinical sites in Turkey and aims to include a total of 676 evaluable subjects (up to 845 randomised).
The study comprises four clinical visits. Consenting subjects will be screened for eligibility (Visit 1; screening) according to study-specific eligibility criteria within 28 days prior to randomisation and start of IMP administration. Eligible subjects will be randomised on Day 1 (Visit 2) to 26 weeks of b.i.d. oral administration of either CMA2 or placebo (1:1). The first dose will be administered at the study clinic. The subjects will be observed for 2 hours post dose for the development of any allergic reactions or intolerance after taking the first dose. Subjects who cannot tolerate the study agents will be withdrawn from the study.
Visits at the study site will be performed at Week 13 (Visit 5) and Week 26 (Visit 8; end of treatment). Monthly telephone contacts will be scheduled with the patients. At the telephone visits IMP compliance, Concomitant medication and adverse event will be addressed.
The following clinical scales will be used to assess the effect of CMA2 on cognition and daily life activity: MMSE, ADAS-Cog, and ADCS-ADL. Blood samples will be collected for advanced plasma metabolomics, proteomics, and lipidomics analysis. Whole genome sequencing will not be performed.
Optional blood samples will be collected for p- tau217, Nfl, GFAP, and S-Urate analysis. Optional Saliva and faeces sampling for oral and gut microbiome will be collected. CSF samples will be optional collected for determination of Abeta42, total-Tau, p-Tau181 levels and Neurofilament light chain concentrations, and for advanced CSF metabolomics, proteomics, and lipidomics analysis. These samples will be decided by each investigator and will be analysed as exploratory endpoint.
- Conditions
- Alzheimer Disease
- Being tested
- Combined metabolic activators, Collagen and maltodextrin
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined metabolic activatorsDrug
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 maltodextrinOther
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 group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Not described Receives: Drug: Combined metabolic activators |
| Placebo Arm | Placebo comparator | Not described Receives: Other: Collagen and maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
MMSE is administered serially to assess the effect of time on the progression of dementia. The MMSE contains seven domains (including orientation, attention, recall) each with an assigned point value totaling 30. Severe cognitive impairment is indicated by a score of (≤9 points) moderate (10- 20 points) and mild (21-24 points). A score of 25 and over indicates normal cognition.
Measured: 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
The 23 ADL items (Activities of Daily Living; 6 basic and 17 instrumental) assess the competence of patients with Alzheimer's Disease in activities of daily living. All responses should relate to the 4 weeks prior to the time of rating. The total score is 0-78, with low scores indicating more severe impairment.
Measured: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
To evaluate compliance daily two doses treatment in patients
The subject will be instructed to bring all unused IMP and empty containers to the clinic visits on Week 13 and Week 26.
Measured: Visit 5 (13 weeks), Visit 8 (26 weeks)
Change in body weight from baseline through-out the study
Body weight will be measured at Visit 1, Visit 5 and Visit 8 to evaluate the safety of metabolic cofactor supplementation.
Measured: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Change in body height from baseline through-out the study
Body height will be measured at Visit 1, Visit 5 and Visit 8 to evaluate the safety of metabolic cofactor supplementation.
Measured: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Change in BMI from baseline through-out the study
BMI will be assessed at Visit 1, Visit 5 and Visit 8 to evaluate the safety of metabolic cofactor supplementation.
Measured: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Change in waist and hip circumference from baseline
Waist and hip circumference will be measured aat Visit 1, Visit 5 and Visit 8 to evaluate the safety of metabolic cofactor supplementation.
Measured: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Change in blood pressure from baseline
Systolic and Diastolic Blood Pressure (mmHg) will be measured at Visit 1, Visit 5 and Visit 8 to evaluate the safety of metabolic cofactor supplementation.
Measured: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Change in heart rate from baseline
Change in heart rate will be measured at Visit 1, Visit 5 and Visit 8 to evaluate the safety of metabolic cofactor supplementation
Measured: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Change in red blood cell count from baseline
Red Blood Cell count test will be performed to measure possible toxic effects of metabolic cofactor supplementation on the hematological system.
Measured: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Change in platelet count from baseline
Platelet count test will be performed to measure possible toxic effects of metabolic cofactor supplementation on the hematological system.
Measured: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Change in hemoglobin concentration from baseline
Hemoglobin concentrations will be assessed to measure possible toxic effects of the metabolic cofactor supplementation on hematological system.
Measured: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Change in white blood cell count from baseline
White blood cell count test will be performed to measure possible toxic effects of the metabolic cofactor supplementation on hematological system.
Measured: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Changes in kidney function tests from baseline
Kidney function tests (creatinine, urea, urate) will be performed to measure possible toxic effects of the metabolic cofactor supplementation on kidney function.
Measured: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Changes in kidney function tests from baseline
Kidney function tests (sodium, potassium) will be performed to measure possible toxic effects of the metabolic cofactor supplementation on kidney function.
Measured: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Changes in liver function tests [Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gamma-glutamyl transferase (GGT), Alkaline phosphatase (ALP)] from baseline
Liver function tests (ALT, AST, GGT, ALP) will be performed to measure possible toxic effects of the metabolic cofactor supplementation on liver function.
Measured: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Changes in liver function tests (Total Bilirubin, and Albumin) from baseline
Liver function tests (Total Bilirubin, Albumin) will be performed to measure possible toxic effects of the metabolic cofactor supplementation on liver function.
Measured: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Changes in creatinine kinase (CK) level from baseline
Creatinine kinase (CK) level will be evaluated to measure possible toxic effects of the metabolic cofactor supplementation.
Measured: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Changes in blood lipid levels (total cholesterol (TC), triglyceride (TG), low density lipoprotein (LDL-C), high density lipoprotein (HDL-C)) from baseline
Blood lipid levels (total cholesterol (TC), triglyceride (TG), low density lipoprotein (LDL-C), high density lipoprotein (HDL-C)) will be evaluated to measure possible toxic effects of the metabolic cofactor supplementation.
Measured: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Changes in blood glucose levels from baseline
Blood glucose levels will be evaluated to measure possible toxic effects of the metabolic cofactor supplementation.
Measured: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Change in blood insulin level from baseline
Blood insulin level will be evaluated to measure possible toxic effects of the metabolic cofactor supplementation.
Measured: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Change in thyroid-stimulating hormone (TSH) level from baseline
Thyroid-stimulating hormone (TSH) level will be evaluated to measure possible toxic effects of the metabolic cofactor supplementation.
Measured: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Monitoring Adverse Events
This process aiming to monitoring of adverse events of metabolic cofactor supplementation. Adverse events, serious adverse events, serious adverse reactions, suspected unexpected serious adverse reactions will be monitored continuously and all events that occur at any time during the study will be reported in Case Report Forms. Any symptoms of intestinal discomfort or other side effects will be carefully recorded and all study subjects will be informed to contact (by phone or text message) the investigators immediately if they experience any symptoms of discomfort or any side effects during the intervention period
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start12 Sep 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 845 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ScandiBio Therapeutics AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sevki SAHIN, Prof. Dr., Principal investigator, Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital, University of Health Sciences Istanbul 34766, Turkiye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062198
- Sponsor's protocol ID
- SB-AD-002
- Acronym
- COGNIS
- Status last verified
- Sep 2025
- First submitted
- 11 Jun 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 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
- ClinicalTrials.gov ID
- NCT07062198
- Acronym / sponsor ID
- COGNIS / SB-AD-002
- Conditions
- Alzheimer Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 845 participants (estimated)
- Lead sponsor
- ScandiBio Therapeutics ABIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This will be a randomised, double-blinded, placebo-controlled, multi-centre Phase 3 study with the aim to establish metabolic improvements in subjects diagnosed with AD by dietary supplementation with CMA2, including NAC, LCAT, niacinamide, and L-serine. The study will be performed at approximately 9 clinical sites in Turkey and aims to include a total of 676 evaluable subjects (up to 845 randomised).
The study comprises four clinical visits. Consenting subjects will be screened for eligibility (Visit 1; screening) according to study-specific eligibility criteria within 28 days prior to randomisation and start of IMP administration. Eligible subjects will be randomised on Day 1 (Visit 2) to 26 weeks of b.i.d. oral administration of either CMA2 or placebo (1:1). The first dose will be administered at the study clinic. The subjects will be observed for 2 hours post dose for the development of any allergic reactions or intolerance after taking the first dose. Subjects who cannot tolerate the study agents will be withdrawn from the study.
Visits at the study site will be performed at Week 13 (Visit 5) and Week 26 (Visit 8; end of treatment). Monthly telephone contacts will be scheduled with the patients. At the telephone visits IMP compliance, Concomitant medication and adverse event will be addressed.
The following clinical scales will be used to assess the effect of CMA2 on cognition and daily life activity: MMSE, ADAS-Cog, and ADCS-ADL. Blood samples will be collected for advanced plasma metabolomics, proteomics, and lipidomics analysis. Whole genome sequencing will not be performed.
Optional blood samples will be collected for p- tau217, Nfl, GFAP, and S-Urate analysis. Optional Saliva and faeces sampling for oral and gut microbiome will be collected. CSF samples will be optional collected for determination of Abeta42, total-Tau, p-Tau181 levels and Neurofilament light chain concentrations, and for advanced CSF metabolomics, proteomics, and lipidomics analysis. These samples will be decided by each investigator and will be analysed as exploratory endpoint.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Combined metabolic activators |
| Placebo Arm | Placebo comparator | Other: Collagen and maltodextrin |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- History of stroke.
- History of brain trauma < 14 days.
- Uncontrolled diagnosed depression.
- Uncontrolled (HbA1C > 8) type 1 or type 2 diabetes.
- Severe swallowing problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined metabolic activatorsA 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. | Drug | Treatment Arm |
| Collagen and maltodextrinAs placebo, a total of 20g of compound primarily containing collagen and maltodextrin will be administered. Placebo contains strawberry aroma flavouring and colouring agent. | Other | Placebo Arm |
Primary outcome
Change in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score from baseline to end-of-treatment
Time frame: 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
23 secondary outcomes
Change in Mini Mental State Examination (MMSE) score from baseline to end-of-treatment
Time frame: 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
Time frame: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
To evaluate compliance daily two doses treatment in patients
Time frame: Visit 5 (13 weeks), Visit 8 (26 weeks)
Change in body weight from baseline through-out the study
Time frame: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Change in body height from baseline through-out the study
Time frame: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Change in BMI from baseline through-out the study
Time frame: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Change in waist and hip circumference from baseline
Time frame: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Change in blood pressure from baseline
Time frame: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Change in heart rate from baseline
Time frame: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Change in red blood cell count from baseline
Time frame: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Change in platelet count from baseline
Time frame: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Change in hemoglobin concentration from baseline
Time frame: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Change in white blood cell count from baseline
Time frame: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Changes in kidney function tests from baseline
Time frame: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Changes in kidney function tests from baseline
Time frame: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Changes in liver function tests [Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gamma-glutamyl transferase (GGT), Alkaline phosphatase (ALP)] from baseline
Time frame: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Changes in liver function tests (Total Bilirubin, and Albumin) from baseline
Time frame: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Changes in creatinine kinase (CK) level from baseline
Time frame: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Changes in blood lipid levels (total cholesterol (TC), triglyceride (TG), low density lipoprotein (LDL-C), high density lipoprotein (HDL-C)) from baseline
Time frame: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Changes in blood glucose levels from baseline
Time frame: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Change in blood insulin level from baseline
Time frame: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Change in thyroid-stimulating hormone (TSH) level from baseline
Time frame: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)
Monitoring Adverse Events
Time frame: 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sevki SAHIN, Prof. Dr. principal investigator
Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital, University of Health Sciences Istanbul 34766, Turkiye
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Combined metabolic activators and Collagen and maltodextrin in people with Alzheimer Disease, run by ScandiBio Therapeutics AB at 8 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sevki SAHIN, Prof. Dr. (+90 216 606 33 00, drsahin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score from baseline to end-of-treatment (time frame: Visit 1, Visit 5 (13 weeks), Visit 8 (26 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.