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.
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…
Contacts
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