Clinical trial: Evaluation of [18F]APN-1607 PET Uptake in Alzheimer's Disease Patients Compared With Healthy Subjects (NCT04141150)

Eligibility criteria:
Inclusion Criteria:

        Inclusion Criteria for All Subjects:

          -  Male or female aged 50 to 85 years, inclusive.

          -  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:

          -  Written informed consent must be obtained before any assessment is performed.

          -  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).

          -  Has a clinical dementia rating (CDR) score of 0.

          -  Has a MMSE score ≥ 27.

          -  The subject has an appropriate informant who agrees to accompany the subject to
             screening to provide information for the CDR. 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.

        Inclusion Criteria for Subjects with MDAD:

          -  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.

          -  Has a CDR score = 0.5.

          -  Has an MMSE score between 24 and 30, inclusive.

          -  Has a positive screening amyloid PET scan.

          -  Medications taken for symptomatic treatment of AD must have been stable for 30 days
             prior to screening and through completion of the neuropsychological battery.

          -  The subject has an appropriate informant to accompany subject for CDR testing and any
             visits, if required for subject or staff comfort or safety.

        Inclusion Criteria for Subjects with AD Dementia:

          -  Written informed consent must be obtained before any assessment is performed. If in
             the Investigator's opinion the patient 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 the local regulations and guidelines and the guidelines of the
             independent ethics committee (IEC) or institutional review board (IRB). When written
             informed consent is provided by a LAR or responsible next of kin, the patient's assent
             must also be obtained and documented.

          -  Has a diagnosis of AD dementia according to NIA-AA criteria, including significant
             impairment of activities of daily living.

          -  Has a CDR score ≥ 0.5 at screening.

          -  Has a MMSE score between 10 and 26, inclusive.

          -  Medications taken for symptomatic treatment of AD must have been stable for 30 days
             prior to screening and through completion of the neuropsychological battery.

          -  Has a positive screening amyloid PET scan.

          -  Medications taken for symptomatic treatment of AD must have been stable for 30 days
             prior to screening and through completion of the neuropsychological battery.

          -  The subject has an appropriate informant to accompany subject for CDR testing and any
             visits, if required for subject or staff comfort or safety.

        Exclusion Criteria:

        Exclusion Criteria for All Subjects:

          -  Current or prior history (within the last 10 years) of alcohol or drug abuse.

          -  Known hypersensitivity to [18F]APN-1607 or its excipients

          -  Clinically significant active or unstable medical illness or planned surgical
             procedures during the study period. History of cancer (other than nonmelanoma skin
             cancers or stable, local prostate cancer), unless without evidence of active disease
             within the last 3 years and without ongoing medical or surgical therapy.

          -  Laboratory tests with clinically significant abnormalities or a history or evidence of
             clinically significant unstable medical illness.

          -  Has received any investigational drug or device for any purpose within 30 days of
             screening (or 5 half-lives of the drug, whichever is longer), has received a
             non-vaccine investigational treatment for AD or other cause of dementia within the
             last 3 months (or 5 half-lives of the drug, whichever is longer), or received a
             passive vaccine for the treatment of AD or other cause of dementia within the last 6
             months, or has ever received an active vaccine for the treatment of AD or other cause
             of dementia.

          -  Prior participation in other research protocols or clinical care in the last year in
             addition to the radiation exposure expected from participation in this clinical study,
             such that radiation exposure exceeds local guidelines, eg, above an effective dose of
             50 mSv in the US.

          -  Pregnant, lactating or breastfeeding.

          -  Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal,
             hematological, neoplastic, endocrine, alternative neurological, immunodeficiency,
             pulmonary, or other disorder or disease.

          -  Unsuitable veins for repeated venipuncture

          -  MRI exclusion criteria include: Findings that may be responsible for the neurologic
             status of the patient such as significant evidence of cerebrovascular disease (more
             than two lacunar infarcts, any territorial infarct >1cm3, or deep white matter
             abnormality corresponding to an overall Fazekas scale of 3 with at least one confluent
             hyperintense lesion on the fluid-attenuated inversion recovery (FLAIR) sequence that
             is ≥20 mm in any dimension), infectious disease, space-occupying lesions, normal
             pressure hydrocephalus or any other abnormalities associated with central nervous
             system (CNS) disease. For subjects with MDAD or AD dementia, there may be evidence of
             atrophy compatible with AD.

          -  Implants, such as implanted cardiac pacemakers or defibrillators, insulin pumps,
             cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS
             aneurysm clips and other medical implants that have not been certified for MRI, or
             history of claustrophobia in MRI.

        Exclusion Criteria for Healthy Subjects:

          -  Meets criteria for a diagnosis of MDAD or dementia or has ever had either diagnosis.

          -  Has ever received treatment with a drug for cognitive impairment or dementia.

        Exclusion Criteria for Subjects with MDAD:

        • Meets criteria for a diagnosis of dementia due to AD.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 85 Years

Patient description (medical language): A 70-year-old man comes to the office accompanied by his wife.  The patient has experienced progressive memory loss over the last years.  He needs help with some of his routine activities, such as paying bills.  The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!"  Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus.  Family history includes Alzheimer disease in his father.  MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria.

Patient description (patient's own words): I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test.

Does the patient match the trial criteria? Entailment