Evaluation of [18F]APN-1607 PET Uptake in Alzheimer's Disease Patients Compared With Healthy Subjects
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|ClinicalTrials.gov Identifier: NCT04141150|
Recruitment Status : Recruiting
First Posted : October 28, 2019
Last Update Posted : October 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease Mild Cognitive Impairment Due to Alzheimer's Disease Healthy Volunteers||Drug: [18F]APN-1607||Phase 2|
The overall objective of this study is to compare the overall pattern of [18F]APN-1607 uptake in subjects with MDAD, subjects with AD dementia, and healthy subjects.
The specific objectives are:
- To expand the safety and tolerability profile for the administration of [18F]APN-1607 and PET scanning.
- To assess regional patterns of [18F]APN-1607 uptake.
- To determine the Braak stage equivalent reflected by [18F]APN-1607 uptake patterns.
- To evaluate the relationship between regional measures of [18F]APN-1607 uptake and demographic characteristics, eg, age and gender; biological characteristics, eg, apolipoprotein E epsilon 4 (APOE4) carrier status and measures of Aβ burden; and clinical characteristics, eg, measurements of AD disease severity, such as National Institute on Aging and Alzheimer's Association (NIA-AA) diagnosis, Mini-mental Status Exam (MMSE) score, and Alzheimer's Disease Assessment Scale-cognitive subscale (ADAScog).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Multicenter Study of [18F]APN-1607 Positron Emission Tomography in Subjects With Alzheimer's Disease Compared to Healthy Subjects|
|Actual Study Start Date :||August 19, 2019|
|Estimated Primary Completion Date :||June 19, 2021|
|Estimated Study Completion Date :||June 19, 2021|
Subjects will undergo PET imaging using [18F]APN-1607.
In this study, all patients will receive one injection of [18F]APN-1607, a PET radiopharmaceutical selective for fibrillar tau. For the injection, subjects will receive a target dose of 7 mCi IV as a bolus injection. [18F]APN-1607 injection will be followed by a 10 ml saline flush.
- Assessment of [18F]APN-1607 Uptake Patterns by Regional SUVR Values [ Time Frame: 22 months ]Regional [18F]APN-1607 uptake patterns will be assessed in regions of interest (ROIs) and an iROI that are relevant to AD pathology. [18F]APN-1607 uptake patterns identified by regional analysis will be compared among healthy subjects, subjects with MDAD, and subjects with AD dementia. Standard uptake value (SUV) will be calculated for each ROI, and SUVRs will be calculated by normalizing SUV of ROIs to the SUV of relevant reference region. Mean and standard deviation of [18F]APN-1607 uptake (ie, SUVR) will be calculated across healthy, MDAD and AD dementia cohorts. Differences between groups will be tested at a P-value of 0.05 using statistical analyses methods (eg, unpaired t-test, ANOVA).
- Safety and Tolerability Profile Measured by Adverse Events (AEs) [ Time Frame: 22 months ]Safety and tolerability profile for the administration of [18F]APN-1607 and positron emission tomography (PET) scanning are measured by number of participants with adverse events (AEs).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04141150
|Contact: Te-Yu Chenemail@example.com|
|Contact: Pou-Jou Chen||886-2-2655-8868 ext firstname.lastname@example.org|
|United States, Connecticut|
|New Haven, Connecticut, United States, 06510|
|Contact: Rhea Martin 203-401-4300 email@example.com|
|Principal Investigator: David Russell, M.D., Ph.D|
|Sub-Investigator: Joyce Gibbons, PA-C|
|Principal Investigator:||David Russell, M.D., Ph.D||Invicro|