RecruitingAlzheimer Disease
A Study of Zunveyl on Safety, Tolerability, Neuropsychiatric Symptoms, and Caregiver Distress in Alzheimer's Disease (RESOLVE)
Eligible age
50+ yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Alpha Cognition, Inc
You may qualify if…
- ✓ 1. Male and female outpatients aged 50 years and greater at the time of informed consent.
- ✓ 2. 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.
- ✓ 3. 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:
- ✓ 1. Less than high school education: SLUMS score 10 -18
- ✓ 2. High school education or higher: SLUMS score 10 - 20
- ✓ 4. 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.
- ✓ 5. Participant currently receiving non-exclusionary chronic medications are eligible, provided doses have been stable for greater than or equal to \[\>=\] 4 weeks.
- ✓ 6. 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.
You may not qualify if…
- ✕ 1. 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.
- ✕ 2. 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.
- ✕ 3. 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.
- ✕ 4. 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:
- ✕ 1. 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).
- ✕ 2. Hematologic, endocrine, metabolic, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disorders that are unstable or progressive.
- ✕ 3. 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.
- ✕ 5. Current active clinical diagnosis of delirium, psychosis or psychotic disorder, per Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07633470 · last updated 2026-07-20