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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50+
SponsorJYAMS PET Research & Development Limited

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.

Eligibility criteria

Qualifiers

Subjects must be able to understand and voluntarily sign a written informed consent form (ICF);

Age ≥ 50 years, regardless of gender;

Subjects with HV, MCI, and AD should meet the clinical diagnostic criteria

Can tolerate brain MRI and PET imaging examinations;

Disqualifiers

Specific clinical phenotypes of atypical AD as defined in the 2014 IWG-2 criteria

Possible presence of frontotemporal degeneration (FTLD), characterized by progressive psych behavioral abnormalities and executive dysfunction,Characterized primarily by impairment and language function, progressive aphasia

The core symptoms of Lewy body dementia include fluctuating cognitive changes accompanied by significant attention and arousal abnormalities, recurrent typical visual hallucinations, and spontaneous symptoms of Parkinson's syndrome;

Currently suffering from significant mental illness. Subjects with accompanying psychiatric symptoms need to be carefully evaluated by the researchers to determine whether they can complete the imaging process;

Trial design

Treatments tested in this trial

  • [18F]-APN-1607

Treatment groups

316 Participants
are divided into 3 treatment groups