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Tests treatment safety and results for Alzheimer Disease
Official title A Study of Zunveyl on Safety, Tolerability, Neuropsychiatric Symptoms, and Caregiver Distress in Alzheimer's Disease (RESOLVE)
ClinicalTrials.gov ID: NCT07633470
What this study is testing
What is Zunveyl®?
Zunveyl® is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for alzheimer disease.
Also referred to as Benzgalantamine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Time commitment: about 12 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join 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...
- Cognitive impairment consistent with mild-to-moderate Alzheimer's disease, confirmed at Screening by the Saint Louis University Mental Status (SLUMS)...
- Less than high school education: SLUMS score 10 -18
- High school education or higher: SLUMS score 10 - 20
You likely can't join if
- Dementia due to causes other than Alzheimer's disease, including but not limited to vascular dementia, frontotemporal dementia, or...
- Negative biomarkers result on the Fujirebio Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test, indicating lack of biomarker support for a...
- Hospitalization in a psychiatric or mental health facility (For example [e.g.], psychiatric hospital, inpatient ward) at screening or within 3 months...
- Any concurrent or unstable medical condition that, in the investigator's judgment, could interfere with study conduct, confound interpretation of...
- Malignancy within the past 2 years, except for adequately treated non-melanotic skin cancer, localized prostate cancer or cervical cancer in situ...
- Hematologic, endocrine, metabolic, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disorders that are unstable or...
See the full eligibility criteria
- 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...
- 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...
- 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.
- 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 how well it works 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 side effects assessments and the Neuropsychiatric Inventory (NPI) across study visits;
- Can observe and accurately report side effects, 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.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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) \ 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...
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Port Orange, Florida, United States
- Palos Hills, Illinois, United States
- St Louis, Missouri, United States
- Albany, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Port Orange, Florida, United States; Palos Hills, Illinois, United States; St Louis, Missouri, United States; Albany, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.