NMRA-323511 for Agitation in Alzheimer's Disease
Recruiting in Palo Alto (17 mi)
+14 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Neumora Therapeutics, Inc.
Trial Summary
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.
Eligibility Criteria
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
Do you experience agitation or irritation related to not being able to remember things?
Exclusion Criteria
Have you been diagnosed with a serious health condition outside of Alzheimer's?
Participant Groups
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.
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 B: PlaceboPlacebo Group1 Intervention
Group IV: Part A: PlaceboPlacebo Group1 Intervention
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Neumora Investigator SiteLomita, CA
Neumora Investigator SiteHialeah, FL
Neumora Investigator SiteHonolulu, HI
Sunwise Clinical ResearchWalnut Creek, CA
More Trial Locations
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Who is running the clinical trial?
Neumora Therapeutics, Inc.Lead Sponsor
References
Efficacy of memantine for agitation in Alzheimer's dementia: a randomised double-blind placebo controlled trial. [2022]Agitation in Alzheimer's disease (AD) is common and associated with poor patient life-quality and carer distress. The best evidence-based pharmacological treatments are antipsychotics which have limited benefits with increased morbidity and mortality. There are no memantine trials in clinically significant agitation but post-hoc analyses in other populations found reduced agitation. We tested the primary hypothesis, memantine is superior to placebo for clinically significant agitation, in patients with moderate-to-severe AD.
Once-daily memantine: a guide to its use in moderate to severe Alzheimer's disease in the EU. [2021]In the EU, once-daily memantine 20 mg (Axura(®), Ebixa(®)) is an option for the management of patients with moderate to severe Alzheimer's disease (AD). In pooled clinical trials and studies in the clinical practice setting, memantine 20 mg/day improved cognition, functional ability and behavioural symptoms in this patient population. The beneficial effects of memantine are associated with delays in the need for full-time care, which were predicted to result in cost savings relative to standard care in recent cost-utility analyses in patients with moderate to severe AD conducted in EU countries. Memantine is well tolerated, with an adverse event profile that is similar to that with placebo.
Clinically meaningful treatment responses after switching to galantamine and with addition of memantine in patients with Alzheimer's disease receiving donepezil. [2021]Clinical trials have shown the benefits of acetylcholinesterase inhibitors, such as donepezil and galantamine, and an N-methyl-D-aspartate receptor antagonist, memantine, in patients with Alzheimer's disease (AD). However, little is known regarding the effects of switching from donepezil 5 mg/day to galantamine 16 or 24 mg/day, or regarding the effects of adding memantine to established therapy compared with increasing the dose of donepezil. This report discusses two studies conducted to evaluate treatment with galantamine and memantine with respect to cognitive benefits and caregiver evaluations in patients with AD receiving donepezil 5 mg/day for more than 6 months. Patients with mild or moderate AD (scores 10-22 on the Mini-Mental State Examination) were enrolled in the Galantamine Switch study and switched to galantamine (maximum doses 16 mg versus 24 mg). Patients with moderate to severe AD (Mini-Mental State Examination scores 3-14) were enrolled in the Donepezil Increase versus Additional Memantine study and either had their donepezil dose increased to 10 mg/day or memantine 20 mg/day added to their existing donepezil dose. Patients received the study treatment for 28 weeks and their Disability Assessment for Dementia, Mental Function Impairment Scale, Cohen-Mansfield Agitation Inventory, and Neuropsychiatric Inventory scores were assessed with assistance from their caregivers. For the Galantamine Switch study after 8 weeks, agitation evaluated by the Cohen-Mansfield Agitation Inventory improved in both the 16 mg and 24 mg groups compared with baseline. However, there were no significant differences between the two galantamine groups. Agitation was also less in patients in the additional memantine group than in the donepezil increase group. In summary, switching to galantamine from donepezil and addition of memantine in patients with AD receiving donepezil were both safe and meaningful treatment options, and particularly efficacious for suppression of agitation.
Effects of Buspirone on Agitation Associated With Dementia. [2019]Ten patients with probable Alzheimer's disease participated in an open-label study of buspirone for agitation. The starting dose of 15 mg/day was increased by 5 mg every week until maximal improvement or 60 mg/day was reached. A significant decrease in agitation scores occurred at an average dose of 35 mg/day.
Efficacy and Safety of Brexpiprazole for the Treatment of Agitation in Alzheimer's Dementia: Two 12-Week, Randomized, Double-Blind, Placebo-Controlled Trials. [2021]To assess the efficacy, safety, and tolerability of brexpiprazole in patients with agitation in Alzheimer's dementia (AAD).