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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

Study Summary

This trial will compare the effects of masupirdine vs. placebo on agitation in people with Alzheimer's Disease.

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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cohen-Mansfield Agitation Inventory (CMAI)
Secondary outcome measures
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
8%
Urinary tract infection
6%
Headache
6%
Diarrhoea
6%
Fall
2%
Syncope
1%
Klebsiella sepsis
1%
Incarcerated inguinal hernia
1%
Dehydration
1%
Malignant neoplasm of unknown primary site
1%
Loss of consciousness
1%
Presyncope
1%
Cardio-respiratory arrest
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
SUVN-502 Low Dose (50 mg)
SUVN-502 High Dose (100 mg)

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

Find a Location

Who is running the clinical trial?

Suven Life Sciences LimitedLead Sponsor
11 Previous Clinical Trials
1,061 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can adults aged 25 and up participate in this experiment?

"This particular trial is designed for patients aged 50 to 90. Out of the 837 total trials, 46 are specifically geared towards those under 18 and 785 are meant for adults 65 or older."

Answered by AI

In how many different places is this trial being run today?

"In addition to the Neurology Center of North Orange County in Fullerton and CCM Clinical Research Group in Miami, there are seven other clinical trial sites currently operational. These locations include the Neuroscience Research Center, LLC in Canton."

Answered by AI

Has the FDA greenlit Masupirdine 100 mg for patient use?

"Given that this is a Phase 3 trial with available data supporting both efficacy and safety, our team has given Masupirdine 100 mg a score of 3 for safety."

Answered by AI

How many people can join this trial at its maximum capacity?

"In order to carry out this clinical trial, 375 willing and eligible participants are required. The patients can come from different locations, such as Neurology Center of North Orange County in Fullerton, Florida and CCM Clinical Research Group in Miami, Ohio."

Answered by AI

Are there specific inclusion criteria for this research project?

"This study is looking for 375 patients that fit the following criteria: Aged between 50-90, have a diagnosis of Alzheimer's dementia according to NIA-AA standards, show signs of agitation according to IPA definitions, and have a MMSE score between 8-24."

Answered by AI

Are there currently any open slots for this research project?

"From what is listed on clinicaltrials.gov, it seems that this particular trial is still looking for patients to participate. This information was originally posted on November 1st, 2022 and the most recent update was on November 17th of the same year."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Pennsylvania
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
What site did they apply to?
ATP Clinical Research, Inc.
Allied Biomedical Research Institute
Other
Baylor College of Medicine

Why did patients apply to this trial?

Mother, grandfather, two uncles died of Alezhiemers!
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. Baylor College of Medicine: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type
2022. "Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05397639.
All > Alzheimers Disease Miami
~115 spots leftby Jan 2025
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