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Masupirdine for Agitation in Alzheimer's Disease

Phase 3
Recruiting
Research Sponsored by Suven Life Sciences Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has a diagnosis of dementia of the Alzheimer's type according to the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria.
Has a score between 8 and 24 (both inclusive) on Mini-Mental State Examination (MMSE).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 12 visit
Awards & highlights

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects aren't listed here, common ones may include gastrointestinal symptoms like nausea or diarrhea, sleep disturbances, headaches, dizziness, or changes in appetite.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Alzheimer's disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 12 visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 12 visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cohen-Mansfield Agitation Inventory (CMAI)
Secondary study objectives
Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGI-C)

Side effects data

From 2019 Phase 2 trial • 564 Patients • NCT02580305
12%
Urinary tract infection
6%
Fall
5%
Diarrhoea
2%
Headache
1%
Diaphragmatic hernia
1%
Rib fracture
1%
Urosepsis
1%
Syncope
1%
Asthenia
1%
Aortic aneurysm
1%
Agitation
1%
Haemorrhage intracranial
1%
Asphyxia
1%
Haemorrhagic anaemia
1%
Gait disturbance
1%
Acute kidney injury
1%
Urinary incontinence
1%
Myocardial infarction
1%
Constipation
1%
Completed suicide
1%
Confusional state
1%
Pneumonia
1%
Sepsis
1%
Acute myocardial infarction
1%
Bradycardia
1%
Cardiomyopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
SUVN-502 High Dose (100 mg)
SUVN-502 Low Dose (50 mg)
Placebo

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low Dose Masupirdine ArmExperimental Treatment1 Intervention
Tablet
Group II: High Dose Masupirdine ArmExperimental Treatment1 Intervention
Tablet
Group III: PlaceboPlacebo Group1 Intervention
Tablet

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Alzheimer's Dementia include cholinesterase inhibitors (e.g., donepezil, rivastigmine), NMDA receptor antagonists (e.g., memantine), and serotonin receptor modulators (e.g., pimavanserin). Cholinesterase inhibitors work by preventing the breakdown of acetylcholine, a neurotransmitter important for memory and learning, thereby enhancing cholinergic function. NMDA receptor antagonists like memantine help regulate glutamate activity to prevent excitotoxicity, which can damage neurons. Serotonin receptor modulators, such as those targeting the 5-HT6 receptor, aim to improve cognitive function by modulating serotonin pathways involved in cognition and behavior. These mechanisms are crucial as they address different aspects of the neurochemical imbalances and neuronal damage seen in Alzheimer's Dementia, potentially improving symptoms and slowing disease progression.
Drug candidates in clinical trials for Alzheimer's disease.

Find a Location

Who is running the clinical trial?

Suven Life Sciences LimitedLead Sponsor
11 Previous Clinical Trials
1,066 Total Patients Enrolled

Media Library

Masupirdine (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05397639 — Phase 3
Alzheimer's Dementia Research Study Groups: Low Dose Masupirdine Arm, Placebo, High Dose Masupirdine Arm
Alzheimer's Dementia Clinical Trial 2023: Masupirdine Highlights & Side Effects. Trial Name: NCT05397639 — Phase 3
Masupirdine (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05397639 — Phase 3
~29 spots leftby Jan 2025