96 Participants Needed

NMRA-323511 for Agitation in Alzheimer's Disease

Recruiting at 20 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Neumora Therapeutics, Inc.

What You Need to Know Before You Apply

What is the purpose of this trial?

This study consists of 2 parts, Part A and Part B. Part A is a single center, randomized, double-blind, placebo-controlled cohort designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of NMRA-323511 among healthy elderly.Part B is a multicenter, randomized, double-blinded, placebo-controlled, parallel-group cohort to evaluate the safety, tolerability, and efficacy of NMRA-323511 among adults with Agitation Associated with Dementia due to Alzheimer's Disease.Part A consists of a Screening Period (up to 28 days), a 10-day Treatment Period, and a 10- day Follow-up clinic visit after last dose of study treatment.Part B consists of a Screening Period (up to 28 days), an 8-week Treatment Period, and a 10-day Follow-up clinic visit after last dose of study treatment.

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 coordinators or your doctor.

What data supports the effectiveness of the drug NMRA-323511 for agitation in Alzheimer's disease?

Research on similar drugs like memantine shows that it can help reduce agitation in Alzheimer's patients, suggesting that NMRA-323511 might have similar benefits.12345

Are You a Good Fit for This Trial?

This trial is for healthy elderly individuals and adults with agitation due to Alzheimer's dementia. Participants must pass a screening and be eligible based on specific criteria not detailed here.

Inclusion Criteria

I am between 65 and 80 years old with a BMI between 18 and 32.
I am 55-90 years old, diagnosed with Alzheimer's, have agitation, and my MMSE score is 5-24.
Do you experience agitation or irritation related to not being able to remember things?

Exclusion Criteria

I have dementia or memory issues not caused by Alzheimer's, or another significant neurological condition.
Have you been diagnosed with a serious health condition outside of Alzheimer's?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Treatment (Part A)

Participants receive NMRA-323511 or placebo for 10 days to evaluate safety, tolerability, and pharmacokinetics

10 days

Follow-up (Part A)

Participants are monitored for safety and effectiveness after treatment

10 days
1 clinic visit

Treatment (Part B)

Participants receive NMRA-323511 or placebo for 8 weeks to evaluate safety, tolerability, and efficacy

8 weeks

Follow-up (Part B)

Participants are monitored for safety and effectiveness after treatment

10 days
1 clinic visit

What Are the Treatments Tested in This Trial?

Interventions

  • NMRA-323511
Trial Overview The study tests NMRA-323511 against a placebo in two parts: Part A focuses on safety in healthy elderly, while Part B assesses safety and effectiveness in those with Alzheimer's-related agitation.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B: NMRA-323511Experimental Treatment1 Intervention
Group II: Part A: NMRA-323511Experimental Treatment1 Intervention
Group III: Part A: PlaceboPlacebo Group1 Intervention
Group IV: Part B: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Neumora Therapeutics, Inc.

Lead Sponsor

Trials
7
Recruited
2,100+

Published Research Related to This Trial

Switching from donepezil to galantamine in patients with Alzheimer's disease showed improvements in agitation after 8 weeks, indicating that this switch is a safe and effective treatment option.
Adding memantine to existing donepezil therapy was also found to be effective in reducing agitation compared to simply increasing the donepezil dose, suggesting that both strategies can provide meaningful benefits for patients.
Clinically meaningful treatment responses after switching to galantamine and with addition of memantine in patients with Alzheimer's disease receiving donepezil.Kano, O., Ito, H., Takazawa, T., et al.[2021]
In a study involving 10 patients with probable Alzheimer's disease, buspirone was found to significantly reduce agitation scores, indicating its potential efficacy for managing agitation in this population.
The optimal average dose for achieving a significant decrease in agitation was 35 mg/day, suggesting that lower doses may be effective before reaching the maximum dose of 60 mg/day.
Effects of Buspirone on Agitation Associated With Dementia.Sakauye, KM., Camp, CJ., Ford, PA.[2019]
In a study involving 149 participants with moderate-to-severe Alzheimer's disease, memantine did not show a significant improvement in clinically significant agitation compared to placebo after 6 weeks, indicating it may not be effective for this symptom.
However, memantine did demonstrate a positive effect on cognitive function and showed some benefits in reducing neuropsychiatric symptoms, suggesting it may still have a role in managing other aspects of Alzheimer's disease.
Efficacy of memantine for agitation in Alzheimer's dementia: a randomised double-blind placebo controlled trial.Fox, C., Crugel, M., Maidment, I., et al.[2022]

Citations

Clinically meaningful treatment responses after switching to galantamine and with addition of memantine in patients with Alzheimer's disease receiving donepezil. [2021]
Effects of Buspirone on Agitation Associated With Dementia. [2019]
Efficacy of memantine for agitation in Alzheimer's dementia: a randomised double-blind placebo controlled trial. [2022]
Efficacy and Safety of Brexpiprazole for the Treatment of Agitation in Alzheimer's Dementia: Two 12-Week, Randomized, Double-Blind, Placebo-Controlled Trials. [2021]
Once-daily memantine: a guide to its use in moderate to severe Alzheimer's disease in the EU. [2021]
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