What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease, such as cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and memantine, have well-documented side effects. Cholinesterase inhibitors often cause gastrointestinal issues like nausea, vomiting, and diarrhea, as well as muscle cramps, fatigue, and insomnia. Memantine is generally better tolerated but can lead to dizziness, headache, confusion, and constipation.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Alzheimer's Disease, primarily focusing on symptom management and slowing disease progression. Notable drugs include cholinesterase inhibitors like donepezil, rivastigmine, and galantamine, which work by increasing levels of acetylcholine in the brain. Another significant approval is memantine, an NMDA receptor antagonist that helps regulate glutamate activity to improve cognitive function. More recently, aducanumab, a monoclonal antibody targeting amyloid-beta plaques, was approved to address the underlying pathology of Alzheimer's. These treatments aim to manage symptoms and modify disease progression, similar to the goals of Varoglutamstat.

What other types of research exist?

Promising novel alternatives to Varoglutamstat for Alzheimer's Disease treatment in 2024 include: 1) Lecanemab, a monoclonal antibody targeting amyloid-beta, which has shown efficacy in slowing cognitive decline in clinical trials. 2) Donanemab, another amyloid-beta targeting antibody, which has demonstrated potential in reducing amyloid plaques and slowing disease progression. 3) Tau protein inhibitors, such as semorinemab, which target tau tangles, a hallmark of AD pathology. These treatments represent significant advancements in the management of Alzheimer's Disease.

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Glutaminyl Cyclase Inhibitor

PQ912 for Alzheimer's Disease (VIVA-MIND Trial)

Phase 2

Waitlist Available

Led By Howard Feldman

Research Sponsored by Vivoryon Therapeutics N.V.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 weeks

Summary

This trial tests a new pill called varoglutamstat for people with early Alzheimer's disease. It aims to see if the drug can safely reduce a harmful brain substance and improve memory and thinking skills. The study will first find the best dose and then check its effects over time.

Who is the study for?

This trial is for people aged 50-89 with early Alzheimer's Disease, scoring within certain ranges on cognitive tests. They need a partner to help them follow the study and must have specific brain scan results and spinal fluid markers. Excluded are those with recent major depression, seizures, other dementia types or severe diseases, liver impairment, bipolar disorder or schizophrenia.

What is being tested?

The trial is testing PQ912 (varoglutamstat) against a placebo in patients with early Alzheimer's over at least 24 weeks. It includes dose adjustments and measures changes in cognitive function and brain activity. If successful, it will expand to assess long-term effects.

What are the potential side effects?

While not explicitly listed here, common side effects of drugs like PQ912 may include gastrointestinal issues, headaches, dizziness or confusion which can be more pronounced due to the patient population's existing condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

2A Primary PK: derived mean values of varoglutamstat levels and corresponding calculated target occupancy (TO)

2A Primary efficacy: The within-participant change from baseline to week 24 in the composite sum of standardized scores from the ADNI Battery Composite (ABC, 9-item) compared between active arm and placebo.

2A Primary efficacy:The within-participant change from baseline to week 24 in quantitative EEG (global relative theta wave power)

+2 more

Secondary study objectives

Key secondary efficacy: CFC2, a cognitive-functional composite

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: 600 mgExperimental Treatment1 Intervention

First 4 weeks 150 mg BID, week 5-8 300 mg BID, week 9-24 600 mg BID

Group II: 300 mgExperimental Treatment1 Intervention

First 4 weeks 150 mg BID, week 5-24 300 mg BID

Group III: 150 mgExperimental Treatment1 Intervention

24 weeks on 150 mg BID

Group IV: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PQ912

2020

Completed Phase 2

~280

Do I qualify?Apply below to find out

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 Disease (AD) often target the amyloid-beta (Aβ) plaques and tau protein tangles that are characteristic of the disease. For example, aducanumab is a monoclonal antibody that reduces amyloid plaques in the brain, potentially slowing cognitive decline. Cholinesterase inhibitors, such as donepezil, rivastigmine, and galantamine, work by increasing levels of acetylcholine, a neurotransmitter important for memory and learning, by inhibiting its breakdown. NMDA receptor antagonists like memantine help regulate glutamate activity to prevent excitotoxicity, which can damage neurons. These mechanisms are crucial as they aim to address the underlying pathophysiology of AD, potentially improving symptoms and slowing disease progression.