Polypill for Alzheimer's Disease

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

103 Participants Needed

Trial Summary

What is the purpose of this trial?

This is an estimation-focused Phase 2 study designed to explore and quantify treatment-related changes across multiple clinical outcomes in patients with Alzheimer's disease over a 180-day period. The anticipated study population are males and females aged 50-85 years with very mild to severe Alzheimer's Disease. The duration of individual patient participation will be approximately 224 Days: up to 14 days for Screening, 180 days for study drug administration, and a final follow-up visit at 210 days. The planned study duration is 12-18 months from Screening of the first patient until the last follow-up of the last patients.

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.

What data supports the idea that Polypill for Alzheimer's Disease is an effective drug?

The available research shows that the Polypill is primarily discussed in the context of heart failure, not Alzheimer's Disease. The studies highlight its use in improving survival rates and quality of life for heart failure patients, especially older adults. However, there is no specific data provided on its effectiveness for Alzheimer's Disease. The research does mention the coexistence of Alzheimer's with heart failure, but it does not provide evidence that the Polypill is effective for treating Alzheimer's Disease itself. ^{1 2 3 4 5}

What safety data is available for the Polypill treatment for Alzheimer's Disease?

The provided research does not directly address safety data for the Polypill treatment for Alzheimer's Disease. The studies focus on heart failure, cognitive impairment, and polypharmacy in heart failure patients, highlighting potential risks of drug interactions and adverse effects in older patients with multiple comorbidities. However, specific safety data for the Polypill in the context of Alzheimer's Disease is not mentioned. ^{1 2 4 5 6}

Is the drug Polypill a promising treatment for Alzheimer's Disease?

The Polypill, which is used for heart failure, could be promising for Alzheimer's Disease because it helps manage heart problems that often occur with Alzheimer's. By improving heart health, it might also help with brain health, potentially benefiting people with Alzheimer's. ^{1 2 4 5 6}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Alzheimer's disease and related dementias and heart failure: A community study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Polypharmacy in Older Heart Failure Patients: a Multidisciplinary Approach. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Prevalence and incidence of cognitive impairment and dementia in heart failure - A systematic review, meta-analysis and meta-regression. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The pharmacological rationale behind polypharmacy in heart failure. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Cognitive function and treatment adherence in older adults with heart failure. [2022]