Evaluation of [18F]APN-1607 PET Uptake in Alzheimer's Disease Patients Compared With Healthy Subjects

Inclusion Criteria

• •1. Males or females aged 50 to 85 years, inclusive.
• •2. 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 using a barrier contraception method or to abstinence for the duration of the study and must have a negative pregnancy test.
• •3. 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.
• •4. Male subjects must not donate sperm for the study duration.
• •5. Willing and able to participate in all study procedures.
• •1. Written informed consent must be obtained before any assessment is performed.
• •2. 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.
• •3. No cognitive impairment based on neuropsychological battery and as judged by the Investigator.
• •4. No first-degree family history of early-onset AD or other neurodegenerative disease associated with dementia (prior to age 65).
• •5. Has a clinical dementia rating (CDR) score of 0.
• •6. Has an MMSE score ≥ 27.
• •7. The subject has an appropriate informant to accompany the subject to screening to provide information for the CDR testing. In the event that the informant cannot accompany the subject to screening, the interview may be performed via phone, at the discretion of the site Investigator.
• •1. Written informed consent must be obtained before any assessment is performed.
• •2. 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.
• •3. Has a CDR score = 0.5.
• •4. Has an MMSE score between 24 and 30, inclusive.
• •5. Has a positive amyloid PET scan obtained during screening or in the past 1 year.
• •6. Medications taken for symptomatic treatment of AD must have been stable for at least 30 days prior to screening and throughout the completion of the neuropsychological battery.
• •7. The subject has an appropriate informant to provide information for the CDR and accompany the subject for any visits, if required for subject or staff comfort or safety.
• •1. Written informed consent must be obtained before any assessment is performed. If in the Investigator's opinion the subject lacks capacity to consent, participation is only possible if the subject has a legally authorized representative (LAR) or responsible next-of-kin and that individual provides written informed consent in accordance with local regulations and guidelines and the rules of the applicable independent ethics committee (IEC)/institutional review board (IRB). When written informed consent is provided by a LAR or responsible next of kin, the subject's assent must also be obtained and documented. For subjects judged lacking capacity to consent, next-of-kin consent in lieu of LAR consent is only allowed where permitted by local laws and regulations.
• •2. Has a diagnosis of AD dementia according to NIA-AA criteria, including significant impairment of activities of daily living.
• •3. Has a CDR score ≥ 0.5 at screening.
• •4. Has an MMSE score between 10 and 26, inclusive.
• •5. Has a positive amyloid PET scan obtained during screening or in the past 1 year.
• •6. Medications taken for symptomatic treatment of AD must have been stable for 30 days prior to screening and throughout the completion of the neuropsychological battery.
• •7. The subject has an appropriate informant to accompany the subject on all visits and provide information for the CDR.