A Study of Zunveyl on Safety, Tolerability, Neuropsychiatric Symptoms, and Caregiver Distress in Alzheimer's Disease (RESOLVE)

NCT07633470 | Recruiting Phase 4 FDA Drug

• 1 other identifier: A1062-401
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to evaluate the safety and tolerability of Zunveyl® over 12 weeks of routine clinical use in adults with mild to moderate Alzheimer's disease.

Conditions

Alzheimer Disease

Keywords

Acetylcholinesterase inhibitor; Galantamine; Delayed-release tablets; Cognitive impairment; benzgalantamine; Zunveyl; nicotinic acetylcholine receptor agonist

Outcome Measures

Primary Outcomes (4)

• Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

  From Week 1 up to Week 12

• Percentage of Participants who Discontinued due to AEs

  From Week 1 up to Week 12

• Number of Participants with Treatment Interruptions or Dose Reductions

  From Week 1 up to Week 12

• Global Tolerability Score

  Functional Assessment of Chronic Illness Therapy (FACIT) General Physical Well-Being domain Item 5 (GP5) will be used to assess the patient-reported impact of treatment toxicity that uses a single item "I am bothered by side effects of treatment" on a 5-point scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much). Higher scores indicate greater bother from treatment side effects and worse treatment toxicity.

  At Weeks 1, 2, 4, 6, 8 12, and 17

Secondary Outcomes (2)

• Change from Baseline in Neuropsychiatric Symptoms as Measured by Neuropsychiatric Inventory - 12 Domain (NPI-12) Total Score up to Week 12

  Baseline up to Week 12

• Change from Baseline in Total Caregiver Distress Score up to Week 12

  Baseline up to Week 12

Study Arms (1)

Zunveyl®

EXPERIMENTAL

Participants will receive Zunveyl® at a dose of 5 milligrams (mg), delayed release tablets, orally, twice daily (BID) from Weeks 1 to 4, followed by 10 mg, delayed release tablets, orally, BID for the subsequent Weeks 5 to12.

Drug: Zunveyl®

Interventions

Zunveyl® DRUG

Zunveyl® delayed release oral tablets.

Also known as: Benzgalantamine

Zunveyl®

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female outpatients aged 50 years and greater at the time of informed consent.
• Diagnosis of probable Alzheimer's disease in accordance with the 2024 National Institute on Aging-Alzheimer's Association (NIA-AA) criteria, supported by biomarker confirmation using the Fujirebio Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test.
• Cognitive impairment consistent with mild-to-moderate Alzheimer's disease, confirmed at Screening by the Saint Louis University Mental Status (SLUMS) examination, with scores meeting the following criteria based on education level:
• Less than high school education: SLUMS score 10 -18
• High school education or higher: SLUMS score 10 - 20
• The participant must be capable of providing informed consent; if not, a legally authorized representative (LAR)/caregiver may provide consent in compliance with federal and Institutional Review Board (IRB) regulations.
• Any recent medication changes at baseline (less than 8 weeks) should be reviewed to confirm they are not expected to confound efficacy or safety assessments.
• Availability of a reliable full-time caregiver or study partner who serves as a knowledgeable informant and:
• Has at least 20 hours per week of direct contact with the participant;
• Is capable of consistently completing tolerability assessments and the Neuropsychiatric Inventory (NPI) across study visits;
• Can observe and accurately report tolerability, neuropsychiatric symptoms (including sleep), and caregiver distress;
• Is available and willing to participate in all required study visits and assessments.
• Participants must not have received disallowed concomitant medications within 2 weeks or 5 half-lives (whichever is longer) prior to baseline.
• Compliance with washouts will be confirmed by medication history review.
• The participant and caregiver must be willing and able to comply with all study procedures, including visits, assessments, and follow-up in an outpatient setting.

You may not qualify if:

• Dementia due to causes other than Alzheimer's disease, including but not limited to vascular dementia, frontotemporal dementia, or substance/medication-induced dementia, Parkinson's disease dementia and Lewy body dementia, Huntington's dementia, or any other types.
• Negative biomarkers result on the Fujirebio Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test, indicating lack of biomarker support for a diagnosis of probable Alzheimer's disease according to the 2024 NIA-AA criteria.
• Hospitalization in a psychiatric or mental health facility (For example \[e.g.\], psychiatric hospital, inpatient ward) at screening or within 3 months prior to screening.
• Any concurrent or unstable medical condition that, in the investigator's judgment, could interfere with study conduct, confound interpretation of study data, or pose an undue risk to the participant's safety. Includes but is not limited to:
• Malignancy within the past 2 years, except for adequately treated non-melanotic skin cancer, localized prostate cancer or cervical cancer in situ (other non-metastatic malignancies may be allowed with medical monitor approval).
• Hematologic, endocrine, metabolic, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disorders that are unstable or progressive.
• Cardiovascular examples: three documented episodes of blood pressure greater than (\>)185/100 millimeters of mercury (mmHg), unstable ischemic heart disease, dilated cardiomyopathy, unstable valvular disease, cardiac conduction abnormalities, or bradycardia (participants will be excluded if resting (awake) heart rate (HR) less than (\<) 50 beats per minute (bpm) confirmed on repeat, or any symptomatic bradycardia.
• Current active clinical diagnosis of delirium, psychosis or psychotic disorder, per Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria.
• Active major depression requiring initiation or recent change of antidepressant therapy within 2 months prior to Screening.
• Active symptoms of diarrhea, nausea, vomiting, or abdominal pain/discomfort or any Gastrointestinal (GI) condition that may impact IP absorption, e.g. gastric bypass surgery during screening or scheduled or prn medications to treat these conditions (e.g., loperamide, ondansetron, antispasmodic drugs).
• History of seizure disorder, anorexia nervosa, or bulimia.
• Acute delirium at baseline (e.g., positive Confusion Assessment Method \[CAM\]) that has not been resolved prior to enrollment.
• Known hypersensitivity or contraindication to Zunveyl® or galantamine-containing products.
• Use of an investigational drug or device for neuropsychiatric symptoms within 30 days or 5 half-lives, whichever is longer prior to Baseline.
• Life expectancy \<12 months, or a hospice/palliative plan of care inconsistent with study participation.

Sponsors & Collaborators

• Alpha Cognition, Inc: lead

Study Sites (1)

Tekton Research Saint Louis Psychiatry

St Louis, Missouri, 63128, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Central Study Contacts

Kurt P Grady, MBA

CONTACT

(618) 407-6732; kgrady@alphacognition.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: June 8, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)