Alzheimer's Disease, Healthy Volunteers, Mild Cognitive Impairment Due to Alzheimer's Disease
Conditions
Keywords
AD, MCI, HV, APN-1607
Brief 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.
Interventions
DRUG[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 5-7 mCi IV as a bolus injection. \[18F\]APN-1607 injection will be followed by a 10 ml saline flush.
Sponsors
APRINOIA Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
Yes
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 before any assessment is performed. * Must meet all of the clinical criteria for MCI according to NIA-AA criteria, including lack of functional impairment sufficient to warrant a diagnosis of dementia. Inclusion Criteria for Subjects with AD: * Has a diagnosis of AD dementia according to NIA-AA criteria, including significant impairment of activities of daily living. * Medications taken for symptomatic treatment of AD must have been stable for 30 days prior to screening and through completion of the neuropsychological battery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of [18F]APN-1607 Uptake Patterns by Regional SUVR Values | 15 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability Profile Measured by Adverse Events (AEs) | 15 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). |
Countries
China
Outcome results
None listed