Polypill for Alzheimer's Disease

Not currently recruiting at 45 trial locations

Overseen By Joshua O Atiba, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Noah Pharmaceuticals, Inc.

Must be taking: Anticholinesterase, Memantine, Herbal

Must not be taking: Cannabidiol, Digoxin, Tetracycline, Sirolimus

Disqualifiers: Neurological disorders, Liver disease, Schizophrenia, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 26 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, called a polypill, to determine its effectiveness for people with Alzheimer's disease, which causes memory and thinking problems. The study compares the effects of the polypill to a placebo (a pill with no active ingredients) over 180 days, aiming to assess the polypill's impact on various Alzheimer's symptoms. Individuals diagnosed with Alzheimer's who have experienced worsening memory and daily function over the past year might be suitable for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in Alzheimer's care.

Do I have to stop taking my current medications for the trial?

You must stop taking statin therapy for the duration of the trial (180 days). If you're on an anticholinesterase inhibitor, memantine, or herbal medication for Alzheimer's, you need to keep the dose stable for the study. The protocol doesn't specify about other medications, but certain drugs like cannabidiol, digoxin, tetracyclines, and sirolimus are not allowed.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that a polypill has been primarily studied for heart conditions, such as heart failure and heart attacks. In these studies, most participants tolerated the polypill well, though some reported side effects like dizziness or stomach issues, which are common with many medications.

As this is a Phase 2 study for Alzheimer's disease, the polypill has already passed initial safety tests. Phase 2 focuses more on the treatment's effectiveness and continues to monitor for any side effects. This phase indicates that the treatment is likely safe, but researchers are still gathering more information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Alzheimer's?

Researchers are excited about the Polypill for Alzheimer's Disease because it combines multiple active ingredients into a single daily tablet, potentially simplifying treatment regimens. Unlike standard treatments that often target only one aspect of the disease, the Polypill aims to address multiple pathways involved in Alzheimer's progression. This comprehensive approach could enhance effectiveness and improve patient adherence by reducing the number of pills patients need to take each day.

What evidence suggests that this treatment might be an effective treatment for Alzheimer's?

Research has shown that the polypill can improve heart health and reduce hospital visits for heart failure by 60%. While this research primarily focuses on heart issues, scientists are also investigating the polypill's potential benefits for Alzheimer's disease. This trial will compare the effects of the polypill with a placebo to explore its impact on Alzheimer's. Since heart and brain health are closely connected, enhancing heart health might also benefit the brain. Ongoing studies are testing this hypothesis, and early results suggest it might help manage Alzheimer's symptoms. However, more data is needed to confirm its effectiveness specifically for Alzheimer's. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

History of cognitive and functional decline over at least 1 year that is either documented in medical records or by history from an informant who knows the patient well

I am between 50 and 85 years old.

I can swallow pills without needing to alter them.

Exclusion Criteria

ALT > 1.5 times the Upper Limit of Normal

AST >1.5 times the Upper Limit of Normal

I have stable depression for over 2 years without thoughts of suicide.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive the study drug or placebo for 180 days

26 weeks

Regular visits (in-person) as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Polypill

Trial Overview

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.

How Is the Trial Designed?

Group I: MAR COMBO Experimental Treatment 1 Intervention

MAR Active 0.6 g, Tablet, once-daily, 180 days

Group II: MAR PLACEBO Placebo Group 1 Intervention

MAR Placebo 0.6 g, Tablet, once-daily, 180 days

Polypill is already approved in India, United States for the following indications:

Approved in India as HFrEF Polypill for:

• Heart failure with reduced ejection fraction

Approved in United States as HFrEF Polypill for:

• Heart failure with reduced ejection fraction

Who Is Running the Clinical Trial?

Noah Pharmaceuticals, Inc.

Lead Sponsor

Trials

1

Recruited

210+

Published Research Related to This Trial

Heart failure treatment often involves multiple medications (polypharmacy) that target various aspects of the disease, which has improved patient outcomes in terms of morbidity and mortality.

However, the complexity of polypharmacy increases the risk of drug interactions and complications from comorbidities, highlighting the need for careful management of medications in heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pharmacological rationale behind polypharmacy in heart failure. Kappert, K., Kusserow, H., Unger, T.[2018]

Recent advancements in treatment options for heart failure (HF) have led to improved survival rates and quality of life, particularly through better medication combinations and device management.

Older patients with HF, often over 65 and with multiple health issues, may not be well-represented in clinical trials, necessitating personalized treatment approaches to avoid adverse effects and drug interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart Failure: Overcoming the Physiologic Dilemma Through Evidence-Based Practice. Melander, S., Miller, S.[2016]

Polypharmacy is common in older adults with heart failure (HF), and while it can be beneficial due to the need for multiple medications, there is a need to redefine what constitutes polypharmacy specifically for this population to better manage their medication burden.

Clinical trials for heart failure treatments have included older adults, particularly those over 65, showing that optimized therapies can improve outcomes; however, there is limited data on the safety of reducing medications in this group, highlighting the need for a multidisciplinary approach to assess the appropriateness of each medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polypharmacy in Older Heart Failure Patients: a Multidisciplinary Approach. Sukumar, S., Orkaby, AR., Schwartz, JB., et al.[2022]

In a study of 149 older adults with heart failure, cognitive impairments in attention, executive function, and language were linked to lower adherence to treatment recommendations, particularly in diet and exercise.

Overall, 16.1% of participants reported poor adherence, highlighting the need for further research to explore how cognitive function affects treatment compliance and to develop strategies to improve health outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive function and treatment adherence in older adults with heart failure. Alosco, ML., Spitznagel, MB., van Dulmen, M., et al.[2022]

In a study of 6,336 heart failure patients, 10% had a diagnosis of Alzheimer's disease or related dementias (AD/ADRD) at the time of their heart failure diagnosis, and 17% developed AD/ADRD within three years after their heart failure diagnosis.

Patients with AD/ADRD had a significantly higher risk of death (up to 3.7 times) and increased hospitalization rates after their heart failure diagnosis, highlighting the critical need for integrated care strategies for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alzheimer's disease and related dementias and heart failure: A community study. Manemann, SM., Knopman, DS., St Sauver, J., et al.[2023]

In heart failure patients, the prevalence of cognitive impairment is notably high at 41.42%, with dementia affecting 19.79% of this population, indicating a significant burden on their health.

The risk of cognitive impairment and dementia in heart failure patients increases with age, suggesting that older patients may require closer monitoring and intervention for cognitive health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and incidence of cognitive impairment and dementia in heart failure - A systematic review, meta-analysis and meta-regression. Yap, NLX., Kor, Q., Teo, YN., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9887530/

Effects of a Polypill, Aspirin, and the Combination of Both on ...

This randomized clinical trial investigates the effectiveness ... cardiovascular death), heart failure, resuscitated cardiac arrest, and arterial ...

2.

newsroom.heart.org

newsroom.heart.org/news/combination-pill-for-heart-failure-improved-heart-function-symptoms-and-quality-of-life

Combination pill for heart failure improved heart function ...

The polypill reduced heart failure-related hospitalizations and emergency room visits by 60%—meaning patients in the polypill group were less ...

3.

mdpi.com

mdpi.com/2077-0383/13/11/3179

The Polypill: A New Alternative in the Prevention ...

Furthermore, the results indicated that one of the most important reasons for the failure ... and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT).

4.

ctv.veeva.com

ctv.veeva.com/study/phase-2b-efficacy-and-safety-study-of-fixed-dose-drugs-combination-type-of-polypill

Phase 2 Estimation Study of Fixed Dose Drugs Combination ...

... outcomes in patients with Alzheimer's disease ... Patient has had a myocardial infarction, unstable angina, stroke, transient ischemic attack ...

5.

tctmd.com

tctmd.com/news/getting-ready-heart-failure-polypill-well-data-are

Getting Ready for a Heart Failure Polypill, Well Before the ...

A new paper in JACC: Advances delves into the factors that may affect implementation of a polypill for heart failure with reduced ejection ...

6.

medicalxpress.com

medicalxpress.com/news/2025-11-combo-pill-boosts-heart-function.html

Combo pill boosts heart function, symptoms, life quality

Adults with heart failure with reduced ejection fraction (HFrEF) ... heart attack patients, and women can have worse outcomes. Aug 30 ...