Alzheimer DiseasePhase 4RESOLVENCT07633470
A Study of Zunveyl on Safety, Tolerability, Neuropsychiatric Symptoms, and Caregiver Distress in Alzheimer's Disease (RESOLVE)
A Phase 4 study testing Zunveyl® in people with Alzheimer Disease, run by Alpha Cognition, Inc at 22 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Zunveyl®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 22 sitesUnited States
- Study dates
- 20 May 2026to Apr 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Participant currently receiving non-exclusionary chronic medications are eligible, provided doses have been stable for greater than or equal to [>=] 4 weeks.
- 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.
Who cannot join
- 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.
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- 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.
- Any medical, neurological, or psychiatric condition that, in the investigator's judgment, may place the participant at risk, interfere with assessments, or compromise study participation.
- Any participant currently receiving or who has ever received Zunveyl®.
- Weight loss of >10 in the 6-month period prior to screening.
- Any planned general surgery during the duration of the study.
- History of Stevens-Johnson Syndrome (TENS).
- Significantly abnormal labs including Estimated Glomerular Filtration Rate (eGFR) <10 or Liver function Tests (LFTs) >2*Upper Limit of Normal (ULN).
- Concomitant medications that cannot be stopped including strong Cytochrome P450 (CYP) inhibitors/inducers of 3A4 or 2D6 or a high anticholinergic burden defined as an Anticholinergic Cognitive Burden (ACB) score > 3 within 28 days prior to baseline. Any new neuropsychiatric medication that would need to be initiated during the study.
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
United States22 sites, 22 recruiting
- Recruiting
Alzheimer's Disease Research Center
Albany, New York, 12208
Richard Holub, 319-426-0575, rholub@naaresearch.com
- Recruiting
First Choice Neurology - Aventura Neurologic Associates
Aventura, Florida, 33180
Jonathan Cross, 303-933-5993, jon.cross@aventuraneuro.com
- Recruiting
Neurology Clinic, P.C.
Cordova, Tennessee, 38018
Thomas Arnold, 901-866-9252, tarnold@neuroclinic.org
- Recruiting
Accel Research - NeuroStudies
Decatur, Georgia, 30033
Marshall Nash, 404-475-0552, marshall.nash@accelclinical.com
- Recruiting
Quest Research Institute
Farmington Hills, Michigan, 48334
Aaron Ellenbogen, 248-957-8940, aaron@questri.com
- Recruiting
NexGen Research
Fort Wayne, Indiana, 46804
Subhash Reddy, 419-516-0954, subhash.reddy@nexgenresearch.com
- Recruiting
Galiz Research
Hialeah, Florida, 33016
Jose Gamez, 305-820-3381, jegamez@galizresearch.com
- Recruiting
Josephson Wallack Munshower Neurology P.C.
Indianapolis, Indiana, 46256
Kristi George, 317-537-6088, kcleveland@jwmneuro.com
- Recruiting
Progeny Psychiatric Clinic - Irvine
Irvine, California, 92614
Linda Trinh, 949-722-7118, lindat@progenyclinic.com
- Recruiting
Mt. Olympus Medical Research, Llc - Katy
Katy, Texas, 77450
Ankit Patel, 346-397-4457, ankit.patel@olympusclinicalresearch.com
- Recruiting
Clincloud, LLC - Viera Office
Melbourne, Florida, 32940
Rosemary Laird, 407-680-0534, rlaird@myclincloud.com
- Recruiting
ActivMed Practices & Research, LLC
Methuen, Massachusetts, 01844
Shay Marc, 978-655-7155, marc.shay@activmedresearch.com
- Recruiting
Allied Biomedical Research Institute (ABRI), Inc
Miami, Florida, 33155
Michael Pfeffer, 305-643-8400, mpfeffer@abriusa.net
- Recruiting
CCM Clinical Research Group, LLC
Miami, Florida, 33155
Francisco Ricart, 305-285-0705, ricart@ccmclinicalresearch.com
- Recruiting
Flourish Research Andersonville
Northbrook, Illinois, 60062
Jeffrey Ross, 513-301-8982, jrossmd1988@yahoo.com
- Recruiting
ATP Clinical Research, Inc - Orange
Orange, California, 92866
Gus Alva, 949-354-5353, galva@atpcr.com
- Recruiting
Essential Concepts Research Solutions (ECRS)
Palos Hills, Illinois, 60465
Wayne Burrows, 217-370-0518, wburrows@ecrs1.org
- Recruiting
Progressive Medical Research
Port Orange, Florida, 32127
Richard Marshall, 386-304-7070, richardm@progressivemedicalresearch.com
- Recruiting
Boeson Research
Provo, Utah, 84604
Jason Andersen, 801-356-5555, dr.andersen@boesonresearch.com
- Recruiting
Tekton Research Saint Louis Psychiatry
St Louis, Missouri, 63128
Ernest Graypel, MD, 314-525-5050, ernest.graypel@missouripsychiatry.com
- Recruiting
Psympatica, LLC
St Louis, Missouri, 63141
Arturo Taca, 314-997-5208, artaca@hotmail.com
- Recruiting
Adams Clinical - Watertown
Watertown, Massachusetts, 02472
Stephanie Rutrick, 617-744-8542, srutrick@adamsclinical.com
About this study
Official title: RESOLVE: A Phase 4, Open-label Study to Assess the Effect of Zunveyl on Safety and Tolerability, Neuropsychiatric Symptoms, and Caregiver Distress in Adults With Mild to Moderate Alzheimer's Disease
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
- Being tested
- Zunveyl®
- Keywords
- Acetylcholinesterase inhibitor, Galantamine, Delayed-release tablets, Cognitive impairment, benzgalantamine, Zunveyl, nicotinic acetylcholine receptor agonist
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zunveyl®Drug
Also called Benzgalantamine
Zunveyl® delayed release oral tablets.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Zunveyl® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: From Week 1 up to Week 12
Percentage of Participants who Discontinued due to AEs
Measured: From Week 1 up to Week 12
Number of Participants with Treatment Interruptions or Dose Reductions
Measured: 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.
Measured: 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
The NPI uses a screening strategy to minimize administration time, examining and scoring only those behavioral domains with positive responses to screening questions. NPI: Total score ranges from 0 to 144, with higher scores indicating worse neuropsychiatric symptoms. Each domain is scored as frequency × severity (0-12 per domain). Assesses 12 domains including delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and night-time behavior disorders, and appetite/eating abnormalities.
Measured: Baseline up to Week 12
Change from Baseline in Total Caregiver Distress Score up to Week 12
The NPI uses a screening strategy to minimize administration time, examining and scoring only those behavioral domains with positive responses to screening questions. NPI: Total score ranges from 0 to 144, with higher scores indicating worse neuropsychiatric symptoms. Each domain is scored as frequency × severity (0-12 per domain). Assesses 12 domains including delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and night-time behavior disorders, and appetite/eating abnormalities.
Measured: Baseline up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start20 May 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alpha Cognition, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633470
- Sponsor's protocol ID
- A1062-401
- Acronym
- RESOLVE
- Status last verified
- Oct 2026
- First submitted
- 19 May 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No