Masupirdine for Agitation in Alzheimer's Disease

Recruiting at 62 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

Trial Summary

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.

What data supports the effectiveness of the drug Masupirdine for agitation in Alzheimer's disease?

Masupirdine is known to block serotonin-6 receptors, which are important for learning and memory, and has shown pro-cognitive effects in animal studies. While there is no direct evidence of its effectiveness for agitation in Alzheimer's, its role in improving cognition suggests potential benefits. ^{1 2 3 4 5}

Is Masupirdine safe for humans?

Masupirdine has been studied for safety in patients with moderate Alzheimer's disease, and it was used alongside other medications like donepezil and memantine. While specific safety details are not provided, its use in clinical trials suggests it has been considered safe enough for human testing. ^{1 2 5 6 7}

How is the drug masupirdine different from other drugs for agitation in Alzheimer's disease?

Masupirdine is unique because it works by blocking serotonin-6 receptors in the brain, which are involved in learning and memory, potentially offering a new way to manage agitation in Alzheimer's disease. Unlike antipsychotics, which can have serious side effects, masupirdine is being studied for its safety and effectiveness without these risks. ^{1 2 4 5 8}

What is the purpose of this trial?

This trial will test a medication called masupirdine, which participants will take regularly. It targets people with Alzheimer's disease who are experiencing agitation. The study aims to see if masupirdine can help reduce agitation and ensure it is safe and well-tolerated. Masupirdine has been previously evaluated in patients with moderate Alzheimer's disease and was found to be generally safe and well-tolerated.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Effect of Concurrent Use of Memantine on the Efficacy of Masupirdine (SUVN-502): A Post Hoc Analysis of a Phase 2 Randomized Placebo-Controlled Study. [2022]

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

Effect of masupirdine (SUVN-502) on cognition in patients with moderate Alzheimer's disease: A randomized, double-blind, phase 2, proof-of-concept study. [2023]

3. England pubmed.ncbi.nlm.nih.gov

A real-world assessment of healthcare costs associated with agitation in Alzheimer's dementia. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Buspirone vs. Haloperidol: A Double-Blind Trial for Agitation in a Nursing Home Population With Alzheimer's Disease. [2019]

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

Risks and benefits of current and novel drugs to treat agitation in Alzheimer's disease. [2022]

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

Low-dose divalproex in agitated patients with Alzheimer's disease. [2013]

7. England 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. [2021]

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

Effect of citalopram on agitation in Alzheimer disease: the CitAD randomized clinical trial. [2022]