Phase 2 Estimation Study of Fixed Dose Drugs Combination Type of Polypill (NCT06597058) | Clinical Trial Compass
CompletedPhase 2
Phase 2 Estimation Study of Fixed Dose Drugs Combination Type of Polypill
United States121 participantsStarted 2024-10-16
Plain-language summary
This is an estimation-focused Phase 2 study designed to explore and quantify treatment-related changes across multiple clinical outcomes in patients with Alzheimer's disease over a 210-day period. The anticipated study population are males and females aged 50-85 years with very mild to severe Alzheimer's Disease. The duration of individual patient participation will be approximately 224 Days: up to 14 days for Screening, 180 days for study drug administration, and a final follow-up visit at 210 days. The planned study duration is 12-18 months from Screening of the first patient until the last follow-up of the last patients.
Who can participate
Age range50 Years – 85 Years
SexALL
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Inclusion criteria
✓. Prior diagnosis of mild-to-severe cognitive impairment or probable AD according to the National Institute on Aging and the Alzheimer's Association guidelines by a qualified health practitioner;
✓. History of cognitive and functional decline over at least 1 year that is either documented in medical records or by history from an informant who knows the patient well;
✓. Male or female, age 50 to 85 years (inclusive) at the Screening Visit;
✓. Patient must be ambulatory and reside with a reliable, competent adult (study partner) who may or may not also be the patient's legally authorized representative (LAR) for informed consent;
✓. Patient must be able to swallow the study medication (without any alteration to the tablet like crushing, cutting in half, or dissolving in a liquid);
✓. Body weight at screening is ≥40kg;
✓. CDR-SB of 3.0 or higher at Screening Visit;
✓. MMSE-2 ≥8 and≤24 at the Screening Visit;
Exclusion criteria
What they're measuring
1
Clinical Dementia Rating - Global Score
Timeframe: Day 210
2
Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score
✕. Patient has had a myocardial infarction, unstable angina, stroke, transient ischemic attack or required intervention for any of these conditions (e.g., coronary artery bypass graft, percutaneous coronary intervention via cardiac catheterization, thrombolytic therapy) within 6 months of the Screening Visit;
✕. Has other neurological disorders, including vascular dementia, Parkinson's disease, frontotemporal dementia, Huntington's disease, amyotrophic lateral sclerosis, multiple sclerosis, progressive supranuclear palsy, neurosyphilis, dementia with Lewy bodies, other types of dementia, mental retardation, hypoxic cerebral damage, and cognitive impairment from head trauma;
✕. Scheduled or anticipates vaccination with a live vaccine during the study;
✕. Current use of a cannabidiol or derivative;
✕. Current use of digoxin;
✕. Acute or chronic liver disease;
✕. AST \>1.5 times the Upper Limit of Normal
✕. ALT \> 1.5 times the Upper Limit of Normal
Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score (Exploratory)