Preclinical Alzheimer's Disease clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT06416072 Enrolling by invitation - Clinical trials for Preclinical Alzheimer's Disease

Alzheimer's Plasma Extension

APEX

Start date: September 21, 2023
Phase:
Study type: Observational

The APEX study is a multicenter, observational study designed to capture longitudinal follow-up of plasma biomarkers and cognitive and functional assessments on individuals who screen failed in the AHEAD study over approximately 4 years. Approximately 1000 participants will be enrolled across three groups: - Group A: Approximately 500 participants who are discordant on screening (plasma positive / Positron Emission Tomography (PET) negative), - Group B: Approximately 250 participants who are concordant on screening (plasma negative / PET negative), and - Group C: Approximately 250 participants selected from the individuals who previously screen failed prior to PET for the AHEAD study with oversampling of racial and ethnic populations underrepresented in Alzheimer's disease (AD) clinical trials. Primary Objectives: - Collect longitudinal cognitive and functional assessments and blood-based biomarker data - Evaluate, characterize, and compare the longitudinal cognitive and functional data between the three groups of participants - Compare longitudinal change across race and ethnicity, sex, and Apolipoprotein E (ApoE) status Exploratory Objectives: • Collect baseline amyloid PET on participants without prior amyloid PET data (Group C)