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

ConditionSubjects With Mild Cognitive Impairment (MCI) of AD, Alzheimer's Disease (AD) Dementia
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • [18F]-APN-1607

    Drug

    Participants will receive a single intravenous injection of 5-7 mCi of \[18F\]-APN-1607, and a whole-body PET/CT scan will begin immediately after administration.

Treatment groups

316 Participants
are divided into 3 treatment groups
Group A: Alzheimer's DiseaseExperimental treatment 1 intervention
Group B: Mild Cognitive Impairment Due to Alzheimer's DiseaseExperimental treatment 1 intervention
Group C: Healthy VolunteersOther 1 intervention

Trial outcomes

Primary outcomes

1

Evaluate the effectiveness of visual reading results of [18 F]-APN-1607 injection PET imaging in detecting tau NFTs（Neurofibrillary Tangles）

Sensitivity and specificity of PET imaging visual interpretation results of \[ 18 F\]-APN-1607 injection compared with true standards

Time frame
15 months

Secondary outcomes

1

Assessment of [18 F]-APN-1607 Uptake Patterns by Regional SUVR Values and the capability in differentiating different groups

Based on \[18F\]-APN-1607 PET, the sensitivity and specificity of area under the curve (AUC) with semi-quantitative analysis of standardized uptake values (SUVR) of brain regions of comprehensive interest (iROI) in the brain to distinguish HV subjects from AD-related cognitive impairment subjects (MCI+AD), as well as MCI subjects from AD subjects.

Time frame
15 months
2

Safety and Tolerability Profile Measured by Adverse Events (AEs)

Safety for theadministration of \[18F\]APN-1607 and PET scanning is measured by number of participants with Adverse events / Serious adverse events

Time frame
15 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

JYAMS PET Research & Development Limited

Lead sponsor

Source ClinicalTrials.gov
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