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Fixed Dose Combination

Polypill for Alzheimer's Disease

Phase 2
Recruiting
Research Sponsored by Noah Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must be able to swallow the study medication (without any alteration to the tablet like crushing, cutting in half, or dissolving in a liquid)
Patients currently treated with a statin must agree to stop their statin therapy for the duration of treatment (180 days)
Must not have
Current use of a cannabidiol or derivative
Acute or chronic liver disease
Timeline
Screening 15 days
Treatment 6 months
Follow Up 1 month

Summary

This trial aims to see how well a combination drug called a polypill works for patients with Alzheimer's Disease over 180 days. They will include male and female patients aged 50-85 with

Who is the study for?
This trial is for men and women aged 50-85 with mild to severe Alzheimer's Disease. Participants will be involved in the study for about 224 days, which includes screening, taking the study drug for 180 days, and a follow-up visit.
What is being tested?
The trial is testing a fixed-dose combination pill called MAR to see how effective it is in treating Alzheimer's over a period of 180 days. The overall duration of the study from start to finish is expected to be between 12-18 months.
What are the potential side effects?
The description provided does not specify side effects; however, common side effects of drugs used in Alzheimer's can include nausea, diarrhea, insomnia, muscle cramps, or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can swallow pills without needing to alter them.
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I agree to stop taking statin medications for 180 days.
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I can walk and live with a responsible adult who can help manage my medication and daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently using cannabidiol or a related product.
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I haven't had a heart attack, stroke, or similar heart issues in the last 6 months.

Timeline

Screening ~ 15 days
Treatment ~ 6 months
Follow Up ~1 month
This trial's timeline: 15 days for screening, 6 months for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score
Secondary study objectives
Adverse Events (AEs)
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-COG)
Alzheimer's Disease Cooperative Study-ADL scale (ADCS-ADL)
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MAR COMBOExperimental Treatment1 Intervention
MAR Active 0.6 g, Tablet, once-daily, 180 days
Group II: MAR PLACEBOPlacebo Group1 Intervention
MAR Placebo 0.6 g, Tablet, once-daily, 180 days

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Noah Pharmaceuticals, Inc.Lead Sponsor
~137 spots leftby Dec 2025
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