- An Evaluation of Treatments for Sustained Clinical Response (18 Months) in Symptomatic Alzheimer’s Disease — Recruiting • Phase III • Neurology • NCT07724132.
- What is being tested: A Phase 3 trial evaluating multiple treatment approaches for sustained clinical response over 18 months in symptomatic Alzheimer's disease, using a randomised, double-blind, placebo-controlled design with multi-arm, multi-stage methodology.
- Patient eligibility overview: The trial targets a UK population representative of people with symptomatic Alzheimer's disease, ensuring findings are applicable to typical NHS patient demographics and disease presentations.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
A multicentre, interventional, multi-arm, multi-stage Phase 3 trial including randomisation, double blinding, placebo control evaluation of treatments for sustained clinical response (18 months) in symptomatic Alzheimer's Disease in a population representative of people with Alzheimer's disease in the UK.
- * Patient meets all inclusion criteria:
- Adults aged ≥55 years on the day of screening, no upper age limit 2. Either: 1. Confirmed clinical diagnosis of Alzheimer's Disease (AD) 2. Confirmed clinical diagnosis of Mixed Dementia consisting of Alzheimer's Disease and Vascular Dementia 3. Mini Mental State Examination score of ≥17 4. Confirmatory blood biomarker testing (pTau-217) (positive or intermediate via validated assays) ≤ 365 days prior to screening or between screening and randomisation or a positive amyloid PET scan (if available) or a positive amyloid CSF test (if available) 5. Randomisation should ideally take place within 4 weeks of the screening visit but no later than 8 weeks after the screening visit 6. Must be able and willing to comply with the treatment and assessment schedule and requirements including being able to start trial treatment ≤ 2 weeks after randomisation 7. Willing and able to have MRI scans in accordance with the assessment schedule unless participant is clinically contraindicated due to: 1. Pacemakers or defibrillators (unless MRI-conditional models) 2. Aneurysm clips, stents or metal implants (unless MRI safe) 3. Cochlear implants (unless MRI-conditional models) 4. Metal fragments in the body 5. Severe claustrophobia 8. Negative pregnancy…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.