Masupirdine for Agitation in Alzheimer's Disease

Recruiting at 69 trial locations

Overseen By Jose De La Gandara, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Suven Life Sciences Limited

Disqualifiers: Non-Alzheimer's dementia, Other psychiatric disorder, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

375 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medication, masupirdine, to determine if it can reduce agitation in people with Alzheimer's disease. The goal is to assess the safety and effectiveness of masupirdine by comparing it to a placebo (a non-active pill). Participants will receive either a low dose, high dose, or placebo to measure different effects. Individuals with Alzheimer's who frequently experience agitation might be suitable for this study. As a Phase 3 trial, this study is the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

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

Research shows that masupirdine is being tested for safety in treating agitation in people with Alzheimer's disease. Although detailed safety information from earlier studies is limited, masupirdine's presence in a late-stage clinical trial suggests it has demonstrated some safety and tolerance in previous research.

At this stage, a treatment has typically been tested in many patients and is considered safe enough for further study. This implies that any serious side effects are likely known, and the treatment is generally well-tolerated. However, like any medication, some side effects may still occur, which will become clearer as more data is collected. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Masupirdine because, unlike current treatments for agitation in Alzheimer's disease, which often focus on sedating patients or altering neurotransmitter levels, Masupirdine targets serotonin receptors specifically. This novel mechanism of action could potentially offer more precise relief from agitation with fewer side effects. Additionally, Masupirdine is available in both low and high doses, providing flexibility to tailor treatment to individual patient needs. This targeted approach could lead to improved quality of life for patients and caregivers alike.

What evidence suggests that masupirdine might be an effective treatment for agitation in Alzheimer's disease?

Research has shown that masupirdine might help reduce agitation and aggression in people with Alzheimer's disease. Earlier studies found that masupirdine significantly lessened these symptoms in some patients. Animal tests also suggest that masupirdine could help with agitation. These early signs offer hope that masupirdine could be a useful treatment for managing agitation in Alzheimer's patients. Further research aims to confirm these results. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for people with Alzheimer's dementia who are experiencing agitation. Participants should score between 8 and 24 on the MMSE, indicating a certain level of cognitive function, and have their agitation confirmed by specific criteria. It's not for those whose agitation might be due to other medical issues or psychiatric disorders unrelated to Alzheimer's.

Inclusion Criteria

I have been diagnosed with Alzheimer's disease.

I have been diagnosed with Alzheimer's disease.

Has a score between 8 and 24 (both inclusive) on Mini-Mental State Examination (MMSE).

Exclusion Criteria

My agitation is not caused by Alzheimer's, pain, psychiatric disorders, infections, or substances.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive masupirdine or placebo orally once-daily for 12 weeks

12 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Masupirdine

Trial Overview

The study tests masupirdine at two different doses (50 mg and 100 mg) against a placebo to see if it can safely reduce agitation in Alzheimer’s patients. The trial will also look into how the body processes the drug.

How Is the Trial Designed?

Group I: Low Dose Masupirdine Arm Experimental Treatment 1 Intervention

Tablet

Group II: High Dose Masupirdine Arm Experimental Treatment 1 Intervention

Tablet

Group III: Placebo Placebo Group 1 Intervention

Tablet

Who Is Running the Clinical Trial?

Suven Life Sciences Limited

Lead Sponsor

Trials

14

Recruited

1,700+

Published Research Related to This Trial

In a pilot study involving 26 nursing home residents with Alzheimer's disease, buspirone (15 mg) was found to reduce agitation and anxiety more effectively than haloperidol (1.5 mg) over a 10-week period.

While the study lacked a placebo group, the results indicate that buspirone may be a promising option for managing agitation in Alzheimer's patients, warranting further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buspirone vs. Haloperidol: A Double-Blind Trial for Agitation in a Nursing Home Population With Alzheimer's Disease. Cantillon, M., Brunswick, R., Molina, D., et al.[2019]

In two 12-week studies involving a total of 703 patients with agitation in Alzheimer's dementia, brexpiprazole at a dose of 2 mg/day showed significant improvement in agitation symptoms compared to placebo, indicating its efficacy in this patient population.

Brexpiprazole was generally well tolerated, with most treatment-emergent adverse events being mild to moderate, although headaches and insomnia were reported more frequently than with placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Brexpiprazole for the Treatment of Agitation in Alzheimer's Dementia: Two 12-Week, Randomized, Double-Blind, Placebo-Controlled Trials. Grossberg, GT., Kohegyi, E., Mergel, V., et al.[2021]

In a case series involving 20 patients with agitation due to Alzheimer's disease, 65% responded positively to low-dose divalproex treatment, indicating its potential efficacy in managing behavioral disturbances.

The study also found that 25% of patients experienced adverse events, suggesting that while low-dose divalproex can improve behavior, there is still a risk of side effects that needs to be monitored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose divalproex in agitated patients with Alzheimer's disease. Dolder, C., McKinsey, J.[2013]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9828442/

Potential beneficial effects of masupirdine (SUVN‐502) on ...

Post hoc analyses suggested masupirdine significantly reduced agitation/aggression, and psychosis in subgroup of patients with AD. Masupirdine is being ...

2.

neurology.org

neurology.org/doi/10.1212/WNL.0000000000209065

Masupirdine (SUVN-502): An Update on the Phase-3 ...

Results from the Phase-3 study will inform the utility of Masupirdine in treating agitation in patients with dementia of the Alzheimer's type.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05397639

NCT05397639 | Masupirdine for the Treatment of Agitation ...

This study will be conducted to evaluate the efficacy, safety, tolerability, and pharmacokinetics of masupirdine compared to placebo for the treatment of ...

4.

alz-journals.onlinelibrary.wiley.com

alz-journals.onlinelibrary.wiley.com/doi/abs/10.1002/alz.087894

Masupirdine (SUVN‐502): Phase‐3 Study for the Potential ...

Outcomes from animal models of aggression and subgroup analysis of the Phase-2 study suggest that masupirdine may alleviate agitation. The Phase ...

5.

neurologylive.com

neurologylive.com/view/masupirdine-improves-agitation-aggression-alzheimer-disease

Masupirdine Improves Agitation and Aggression in ...

A phase 3 trial has been initiated to further study masupirdine's effect on agitation in patients with Alzheimer dementia.

6.

alz-journals.onlinelibrary.wiley.com

alz-journals.onlinelibrary.wiley.com/doi/abs/10.1002/alz.074068

Masupirdine (SUVN‐502) for the Potential Treatment of ...

The Phase-3 study results will inform the utility of masupirdine for the potential treatment of agitation in patients with dementia of ...

7.

connect.careboxhealth.com

connect.careboxhealth.com/en-US/trial/listing/352635

Masupirdine for the Treatment of Agitation in Dementia ...

This study will be conducted to evaluate the efficacy, safety, tolerability, and pharmacokinetics of masupirdine compared to placebo for the treatment of ...