150 Participants NeededMy employer runs this trial

Zunveyl for Alzheimer's Disease

(RESOLVE Trial)

Recruiting at 19 trial locations
KP
Overseen ByKurt P Grady, MBA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called Zunveyl® to determine its safety and tolerability in people with mild to moderate Alzheimer's disease over 12 weeks. Participants will take Zunveyl® tablets twice daily, with the dose increasing after the first four weeks. Ideal participants have an Alzheimer's diagnosis and a reliable caregiver to assist with the study. This trial does not suit individuals with other types of dementia or certain medical conditions that could interfere with the study. As a Phase 4 trial, Zunveyl® has already received FDA approval and proven effective, and this research aims to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial allows participants to continue taking their current medications if the doses have been stable for at least 4 weeks. However, certain medications, especially those with a high anticholinergic burden or strong interactions, may need to be stopped at least 28 days before starting the trial.

What is the safety track record for Zunveyl®?

Previous studies have shown that Zunveyl is a well-tolerated treatment for mild to moderate Alzheimer's disease. The FDA has already approved it for this purpose, indicating thorough safety testing. While some patients may require monitoring for seizures, this is a common precaution for similar medications. Overall, the treatment is considered safe for most people, and medical guidance can manage any side effects.12345

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for Alzheimer's disease, which often focus on managing symptoms with medications like donepezil or memantine, Zunveyl® offers something different. Researchers are excited about Zunveyl® because it employs a unique delayed-release tablet formulation that allows for a twice-daily dosing schedule. This delivery method could potentially improve the medication's effectiveness and provide more consistent symptom management. Additionally, the treatment's gradual dosage escalation from 5 mg to 10 mg over 12 weeks may help in minimizing side effects, making it a promising option for patients and caregivers.

What is the effectiveness track record for Zunveyl® in treating Alzheimer's disease?

Research has shown that Zunveyl® effectively treats Alzheimer's disease. In a study with 978 patients with mild to moderate Alzheimer's, the main ingredient, galantamine, helped maintain cognitive abilities. Additionally, 92% of patients experienced improvements in their thinking after starting Zunveyl. The treatment reduced the risk of severe dementia and death. The FDA has approved Zunveyl for treating mild to moderate Alzheimer's, supporting its effectiveness.35678

Are You a Good Fit for This Trial?

This trial is for adults aged 50 and older with mild to moderate Alzheimer's disease, confirmed by a blood test. Participants must have a caregiver who spends at least 20 hours per week with them and can help report symptoms. People on stable medications may join if their doses haven't changed recently.

Inclusion Criteria

I have probable Alzheimer's disease confirmed by a specific blood test.
Cognitive impairment consistent with mild-to-moderate Alzheimer's disease confirmed by SLUMS exam with scores 10-18 for less than high school education and 10-20 for high school education or higher
I am able to give informed consent or have a legal representative to do so.
See 7 more

Exclusion Criteria

Hospitalization in psychiatric or mental health facility at screening or within 3 months prior
I do not have serious or unstable heart or blood pressure problems.
I currently have a diagnosis of delirium or a psychotic disorder.
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Zunveyl® at a dose of 5 mg BID from Weeks 1 to 4, followed by 10 mg BID for Weeks 5 to 12

12 weeks
Visits at Weeks 1, 2, 4, 6, 8, and 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 weeks
Visit at Week 17

What Are the Treatments Tested in This Trial?

Interventions

  • Zunveyl®

Trial Overview

The study is testing the safety and tolerability of Zunveyl® over 12 weeks in people with mild to moderate Alzheimer's disease. Caregivers will also report on neuropsychiatric symptoms and their own stress levels during this period.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Zunveyl®Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alpha Cognition, Inc

Lead Sponsor

Citations

Investors News

Providers reported cognitive improvement in 92% of patients following initiation of ZUNVEYL; Providers reported improvement in neuropsychiatric ...

A Study of Zunveyl on Safety, Tolerability, Neuropsychiatric ...

The primary purpose of this study is to evaluate the safety and tolerability of Zunveyl® over 12 weeks of routine clinical use in adults ...

Clinical Studies - ZUNVEYL is the first and only FDA-approved ...

In a 21-week study of 978 patients with mild to moderate Alzheimer's disease, galantamine (the active ingredient of ZUNVEYL) showed sustained cognitive benefits ...

AChEI Inhibitor Benzgalantamine (Zunveyl) Commercially ...

Benzgalantamine was associated with lower risk of death (0.71, 95% CI 0.65–0.76) and lower risk of severe dementia (0.69, 95% CI 0.47–1.00) and ...

FULL PRESCRIBING INFORMATION - accessdata.fda.gov

The effectiveness of galantamine as a treatment for Alzheimer's disease is demonstrated by the results of 5 randomized, double-blind, placebo-controlled ...

6.

zunveyl.com

zunveyl.com/

Home - ZUNVEYL is the first and only FDA-approved ...

ZUNVEYL is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer's type in adults. IMPORTANT SAFETY INFORMATION.

FDA Approves New-Generation Acetylcholinesterase ...

Marketed as Zunveyl for mild-to-moderate Alzheimer disease, ALPHA-1062 is considered a new-generation acetylcholinesterase inhibitor with ...

FDA Approval to Treat Alzheimer's Disease

ZUNVEYL's innovative approach targets AD symptoms directly, designed to provide patients with significant benefits to cognitive and global function.