Combined Metabolic Activator Supplementation in Subjects Diagnosed With Alzheimer's Disease
Recruiting
Phase 3Interventional Study
Alzheimer Disease
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Supportive Care
Participants needed
845 (estimated)
Sponsor
ScandiBio Therapeutics AB · Industry
Who this trial is looking for
This trial is looking for adults aged 50 and older who have been diagnosed with Alzheimer's Disease. Participants will take a supplement or a placebo twice a day for 26 weeks and visit the clinic four times for checkups and tests.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 50 years old.
I have been diagnosed with Alzheimer's Disease.
My Alzheimer's treatment and condition have been stable for at least 1 month.
I can provide written consent to participate.
You may not be able to join if
I have a history of stroke.
I have had brain trauma in the last 14 days.
I have uncontrolled depression.
I have uncontrolled diabetes.
I have serious swallowing problems.
I have chronic kidney disease.
I have a known allergy to study substances.
I have participated in another clinical study in the last 3 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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.
Trial Locations
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Status
Eligibility Criteria
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 docum…
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.
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