Evaluating a new PET imaging agent in Alzheimer's disease patients
Director of Nuclear Medicine Department
This study is testing a new imaging agent to see if it can safely help track Alzheimer's disease in people aged 45 to 80.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | All |
| Sponsor | Nanjing First Hospital, Nanjing Medical University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Nanjing) |
| Trial ID | NCT05043675 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and tolerability of the imaging agent [18F]APN-1607 in patients diagnosed with Alzheimer's disease (AD) dementia. It will evaluate the regional patterns of [18F]APN-1607 uptake through PET scanning and explore the relationship between these uptake patterns and various measures of AD severity, including cognitive assessments. The study will involve participants aged 45 to 80 years who meet specific diagnostic criteria for AD.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45 to 80 with a confirmed diagnosis of Alzheimer's disease dementia and specific cognitive impairment.
Not a fit: Patients with other neurological disorders or those not meeting the diagnostic criteria for Alzheimer's disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of Alzheimer's disease progression and improve diagnostic imaging techniques.
How similar studies have performed: While there have been studies using PET imaging in Alzheimer's disease, the specific use of [18F]APN-1607 is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female aged 45 to 80 years, inclusive. * 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 ≤ 25. * Brain MRI supports the diagnosis of AD and there is no evidence of other nervous system diseases. * Medications taken for symptomatic treatment of AD must have been stable for 30 days prior to screening and through completion of the neuropsychological battery. * If necessary, the subject can be accompanied by nursing staff. * 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. Exclusion Criteria: * Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease. * 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. * Intolerance to MRI noise or hermetic phobia. * 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. * Current or prior history (within the last 10 years) of alcohol or drug abuse. * Pregnant, lactating or breastfeeding. * Unsuitable veins for repeated venipuncture * 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). * Known hypersensitivity to \[18F\]APN-1607 or its excipients * Has received a non-vaccine investigational treatment for Aβ within the last 3 months. * Has received a non-vaccine investigational treatment for tau within the last 3 months. * Any situation that the presiding officer of this study believes may cause harm or potential harm to any link related to this test.
Where this trial is running
Nanjing
- Nanjing First Hospital — Nanjing, China (Recruiting)
Study contacts
- Study coordinator: Feng Wang
- Email: fengwangcn@hotmail.com
- Phone: 02552271491
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.