Evaluate the Use of [18F]-APN-1607 PET in Subjects With AD-related Cognitive Impairment and Subjects With Normal Cognitive Function

Recruiting Phase 3 Interventional Study
Subjects With Mild Cognitive Impairment (MCI) of AD, Alzheimer's Disease (AD) Dementia
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
50 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Diagnostic
Participants needed
316 (estimated)
Sponsor
JYAMS PET Research & Development Limited · Industry
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About This Trial

This study is to evaluate the efficacy and safety of \[18F\]-APN-1607 Injection in PET imaging for detecting AD-related cognitive impairment.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Subjects must be able to understand and voluntarily sign a written informed consent form (ICF); 2. Age ≥ 50 years, regardless of gender; 3. Subjects with HV, MCI, and AD should meet the clinical diagnostic criteria 4. Can tolerate brain MRI and PET imaging examinations; 5. Fo…
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