Georgia Memory Net Anti-Amyloid Monoclonal Antibody Registry
Georgia Memory Net Center for Medicare and Medicaid Services Registry for Anti-Amyloid Monoclonal Antibody Coverage With Evidence Development
Sponsor: Emory University + Centers for Medicare and Medicaid Services
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Change in Quick Dementia Rating System (QDRS) Score
Time frame: Baseline and every 6 months until end of study (up to 5 years)
Montreal Cognitive Assessment (MoCA) Score
Time frame: Baseline and every 6 months until end of study (up to 5 years)
Change in Functional Activities Questionnaire (FAQ) Score
Time frame: Baseline and every 6 months until end of study (up to 5 years)
Change in Lawton-Brody Activities of Daily Living (ADL) Physical Self-Maintenance Scale (PSMS) Score
Time frame: Baseline and every 6 months until end of study (up to 5 years)
Secondary Endpoints
Change in Care Needs Assessment Tool (CNAT) Score
Change in Zarit Burden Interview Score
Change in Patient-Reported Outcomes Measurement Information System Global Health (PROMIS 10) Score
Eligibility Criteria
Inclusion Criteria: 1. Age 50-90, inclusive 2. Diagnosis: Mild Cognitive Impairment (MCI) or mild AD dementia with positive cerebrospinal fluid (CSF) or amyloid PET 3. Objective measurement of baseline cognition and function within past 3 months: * Cognitive: Mini-Mental State Examination (MMSE) ≥ 22, MoCA ≥ 16 * Function: Independence in basic ADLs * Function: FAQ ≤ 9 may justify inclusion with lower cognitive score if felt to be impacted by prominent language impairment or other factors affecting score 4. MRI brain within last year and no exclusionary criteria 5. Complete blood count (CBC), comprehensive metabolic panel (CMP), B12, thyroid stimulating hormone (TSH), prothrombin time (PT), partial thromboplastin time (PTT), and International Normalized Ratio (INR) without clinically significant abnormality 6. Informant/care partner/family available to attend follow-up visits to provide information regarding patient's cognitive and functional abilities 7. Agree to MRI, PET, …
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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