What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Dementia include cholinesterase inhibitors (e.g., donepezil, rivastigmine) and NMDA receptor antagonists (e.g., memantine). Cholinesterase inhibitors often cause gastrointestinal side effects such as nausea, vomiting, and diarrhea, as well as muscle cramps and fatigue. Memantine can lead to dizziness, headache, confusion, and constipation. Antipsychotic medications, sometimes used for neuropsychiatric symptoms, carry risks of sedation, weight gain, metabolic syndrome, and increased mortality in elderly patients with dementia. Serotonin receptor modulators like pimavanserin, similar to Masupirdine, may cause side effects such as peripheral edema, nausea, and QT prolongation.

What prior FDA approvals exist?

FDA-approved treatments for Alzheimer's Dementia include cholinesterase inhibitors such as donepezil, rivastigmine, and galantamine, which work by increasing levels of acetylcholine in the brain. Another approved drug is memantine, an NMDA receptor antagonist, which helps regulate glutamate activity. While these drugs are not Serotonin 5-HT6 receptor antagonists like Masupirdine, they represent the main classes of medications currently approved for managing Alzheimer's symptoms. There is limited information on FDA-approved treatments specifically targeting the Serotonin 5-HT6 receptor for Alzheimer's Dementia.

What other types of research exist?

Promising alternatives to Masupirdine for Alzheimer's Dementia patients include: 1) Lecanemab, a monoclonal antibody targeting amyloid-beta, which has shown positive results in reducing cognitive decline. 2) Donanemab, another monoclonal antibody targeting amyloid plaques, currently in advanced clinical trials. 3) Blarcamesine (Anavex 2-73), a sigma-1 receptor agonist and muscarinic receptor modulator, showing potential in improving cognitive function. 4) ALZ-801, an oral agent targeting amyloid oligomers, which has shown promise in clinical studies. These alternatives represent diverse mechanisms of action and are at various stages of clinical development.

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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

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to week 12 visit

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

Fall

Diarrhoea

Headache

Aortic aneurysm

Urinary incontinence

Completed suicide

Constipation

Acute kidney injury

Asphyxia

Confusional state

Diaphragmatic hernia

Myocardial infarction

Urosepsis

Syncope

Haemorrhage intracranial

Rib fracture

Agitation

Asthenia

Gait disturbance

Haemorrhagic anaemia

Pneumonia

Sepsis

Acute myocardial infarction

Bradycardia

Cardiomyopathy

100%

80%

60%

40%

20%

Study treatment Arm

SUVN-502 High Dose (100 mg)

SUVN-502 Low Dose (50 mg)

Placebo

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 2Eligibility criteria met

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.