[18F]APN-1607 PET in Subjects With AD Compared to HC (NCT05542953) | Clinical Trial Compass
CompletedPhase 3
[18F]APN-1607 PET in Subjects With AD Compared to HC
China230 participantsStarted 2022-01-21
Plain-language summary
The overall objective of this study is to compare the overall pattern of \[18F\]APN-1607 uptake in subjects with MCI, subjects with AD dementia, and healthy subjects.
Who can participate
Age range50 Years – 85 Years
SexALL
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Inclusion Criteria:
Inclusion Criteria for All Subjects:
* Written informed consent must be obtained before any assessment is performed.
* Female subjects must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral oophorectomy, or tubal ligation) or post-menopausal for at least 1 year (ie, 12 consecutive months with no menses without an alternative medical cause) or, if they are of childbearing potential, must commit to use a barrier contraception method or to abstinence for the duration of the study and must have negative serum and urine pregnancy tests.
* Male subjects and their partners of childbearing potential must commit to the use of two methods of contraception, one of which is a barrier method (ie, condom), or to abstinence for the study duration.
* Male subjects must not donate sperm for the study duration.
* Willing and able to participate in all study procedures.
Inclusion Criteria for Healthy Subjects:
* Medically healthy with no clinically relevant finding on physical examination, laboratory profiles, VS, or ECG at screening and upon reporting for the \[18F\]APN-1607 Imaging Visit.
* No cognitive impairment based on neuropsychological battery and as judged by the Investigator.
* No first-degree family history of early-onset AD or other neurological disease associated with dementia (prior to age 65).
Inclusion Criteria for Subjects with MCI:
* Written informed consent must be obtained befor…
What they're measuring
1
Assessment of [18F]APN-1607 Uptake Patterns by Regional SUVR Values