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Tau PET Imaging Tracer for Alzheimer's Disease

Recruiting

This study will test a new tracer, 18F-APN-1607, for identifying tau on positron emission tomography (PET) scans of people with and without cognitive impairment due to Alzheimer's disease. Researchers are developing the tracer for potential use in early detection of dementia and in testing tau-based treatments.

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 85 Years All Yes
August 19, 2019
June 19, 2021
130

Inclusion Criteria for All Participants:

  • If female, must be surgically sterile (by means of hysterectomy, bilateral oophorectomy, or tubal ligation) or post-menopausal for at least one year, or commit to using a barrier contraceptive or abstinence for the study duration; must not be pregnant
  • Male participants and their partners of childbearing potential must commit to using two methods of contraception, one of which is a barrier method (e.g., condom), or to abstinence for the study duration; must not donate sperm for the study duration

Inclusion Criteria for Healthy Participants:

  • Medically healthy with no clinically relevant finding on physical examination, laboratory profiles, vascular scan, or ECG at screening and imaging appointment
  • No cognitive impairment or previous treatment with a drug for cognitive impairment or dementia
  • No first-degree family history (e.g., father, mother, brother, or sister) of early-onset Alzheimer's disease or other neurological disease associated with dementia (prior to age 65)
  • Clinical Dementia Rating (CDR) score of 0
  • Mini-Mental State Examination (MMSE) score >27
  • Study partner who can attend screening and provide information for the CDR. If necessary, the interview may be performed via phone, at the discretion of the study contact

Inclusion Criteria for Participants With Mild Cognitive Impairment: 

  • Meet clinical criteria for mild cognitive impairment due to Alzheimer's disease
  • CDR score of 0.5
  • MMSE score between 24 and 30
  • Positive amyloid PET scan
  • Use of any Alzheimer's medications stable for at least 30 days prior to and through screening
  • Study partner who can accompany participant for CDR testing and any visits, if required for comfort or safety

Inclusion Criteria for Participants With Alzheimer's Disease: 

  • Diagnosis of Alzheimer's disease, including significant impairment of daily living activities
  • CDR score >0.5 at screening
  • MMSE score between 10 and 26
  • Use of any Alzheimer's medications stable for at least 30 days prior to and through screening
  • Positive amyloid PET scan
  • Study partner who can accompany participant for CDR testing and any visits, if required for comfort or safety

  • Current or prior history (within the last 10 years) of alcohol or drug abuse
  • Known hypersensitivity or allergy to the tracer, 18F-APN-1607, or any of the other ingredients in the tracer solution
  • History or presence of clinically significant active or unstable medical illness
  • Planned surgical procedures during the study period
  • History of cancer (other than nonmelanoma skin cancers or stable, local prostate cancer), unless evidence of no active cancer within the last 3 years and without ongoing medical or surgical therapy
  • Laboratory tests with clinically significant abnormalities
  • Received any research study drug or device for any purpose within 30 days of screening (or enough time for the drug to be cleared from the body, whichever is longer)
  • Received a nonvaccine research study treatment for Alzheimer's or other dementia within the last three months (or enough time for the drug to be cleared from the body, whichever is longer)
  • Received a passive vaccine for treatment of Alzheimer's or other dementia within the last six months or an active vaccine treatment at any time
  • Radiation exposure in the last year that combined with the exposure expected from this study would exceed guidelines
  • Pregnant, lactating, or breastfeeding
  • Evidence of gastrointestinal, cardiovascular, liver, kidney, blood, neoplastic, endocrine, alternative neurological, immunodeficiency, lung, or other disorder or disease
  • Unsuitable veins for repeated injections
  • Inability to undergo MRI, such as an implanted device (e.g., cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, aneurysm clips), or history of claustrophobia during MRI
  • Evidence on MRI of findings that may suggest other causes for the participant's neurologic status, such as cerebrovascular disease, infectious disease, space-occupying lesion in the brain, or normal pressure hydrocephalus

Tau PET scans detect abnormal accumulation of a protein, tau, which forms tangles in nerve cells in Alzheimer's disease and other dementias. The amount and patterns of tau tangles in the brain are known to be different depending on the stage of dementia.

This phase 2 clinical trial will test the use of a radioactive tau tracer, 18F-APN-1607, in a PET scan to identify the amounts and patterns of tau in the brains of people with mild cognitive impairment or Alzheimer's disease compared to the scans of people with no cognitive impairment. All participants will receive a PET brain scan using the novel tracer and will be monitored for safety and any side effects for 22 months.

Name City State Zip Status Primary Contact
Invicro
New Haven Connecticut 06510 Recruiting Rhea Martin
203-401-4300
rmartin@invicro.com

Aprinoia Therapeutics Inc.

Name Role Affiliation
David Russell, M.D., Ph.D Principal Investigator Invicro

Name Phone Email
Te-Yu Chen 886-2-2655-8868 tychen@aprinoia.com
Pou-Jou Chen 886-2-2655-8868 pjchen@aprinoia.com

NCT04141150

A Phase 2, Multicenter Study of [18F]APN-1607 Positron Emission Tomography in Subjects With Alzheimer's Disease Compared to Healthy Subjects