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Tau Screening Study in Subjects With Early Symptomatic AD

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ClinicalTrials.gov Identifier: NCT03467477
Recruitment Status : Recruiting
First Posted : March 16, 2018
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Brief Summary:
This protocol is designed to serve as a pre-screening study for subjects who are potentially eligible for Alzheimer's Disease (AD) therapeutic trials that require tau imaging for inclusion by means of a flortaucipir F18 Positron Emission Tomography (PET) scan.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: 18F-AV-1451 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Multicenter Screening Study With Flortaucipir F 18 in Patients With Early Symptomatic AD; #2
Actual Study Start Date : March 8, 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Subjects with Early Symptomatic AD
Patients who receive 18F-AV-1451 dose after being successfully screened and are interested in participating in AD therapeutic clinical trials (and are not known to meet any exclusion criteria for those AD therapeutic clinical trials).
Drug: 18F-AV-1451
Subjects will receive single IV administration of 370 megabecquerel (MBq)(10 millicurie [mCi]) of 18F-AV-1451
Other Names:
  • Flortaucipir F18
  • [F-18]T807
  • LY3191748



Primary Outcome Measures :
  1. Completion of a flortaucipir F18 PET scan [ Time Frame: Dose administration within 30 days of screening assessment ]
    There is no formal hypothesis to test in this screening study. The study will pre-screen patients via a flortaucipir F18 scan who have cognitive impairment and etiology diagnosed or suspected to be AD, and have interest in participating in trials that require tau imaging for inclusion. The outcome measure will report the number of subjects pre-screened.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with gradual and progressive change in memory function reported by the patient or informant for ≥6 months
  2. Patients who have a MMSE score between 20-27 inclusive
  3. If available at the site, a CBB (learning/working memory score of 80 to 90); NOTE: A qualifying inclusionary CBB score trumps an exclusionary MMSE score if both are performed at a site
  4. Patients who are willing to undergo a PET scan using flortaucipir F 18
  5. Patients who give informed consent or have a legally authorized representative (LAR) available to consent at the time of enrollment
  6. A study partner who must be available if the patient enters the treatment trial

Exclusion Criteria:

  1. Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. Females of childbearing potential must not be pregnant (negative serum β-HCG at screening and negative urine β-HCG prior to flortaucipir F 18 injection) or breastfeeding at screening. Females should agree to avoid becoming pregnant by refraining from sexual activity or using reliable contraceptive methods for 24 hours following administration of flortaucipir F 18 injection;
  2. Patients who lack, in the investigator's opinion, adequate premorbid literacy, adequate vision, or adequate hearing to complete the required psychometric testing;
  3. Have significant neurological disease affecting the CNS, other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures (except febrile childhood seizures);
  4. Patients with any current primary psychiatric diagnosis other than AD if, in the judgment of the investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessment, or affect the patient's ability to complete the study [Patients with history of schizophrenia or other chronic psychosis are excluded.];
  5. Have a current serious or unstable illness including, cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study; or has a life expectancy of <24 months;
  6. Has a history of cancer within the last 5 years, with the exception of nonmetastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, non-progressive prostate cancer, or other cancers with low risk of recurrence or spread;
  7. Have a past history (suspected or confirmed) of Hepatitis B or Hepatitis C;
  8. Are clinically judged by the investigator to be at serious risk for suicide as assessed by medical history, examination, or the C-SSRS.
  9. Have a history of alcohol or drug disorder (except tobacco use disorder) within 2 years before the screening visit;
  10. Have a history of clinically significant multiple or severe drug allergies or severe post treatment hypersensitivity reactions (including but not limited to erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, and/or exfoliative dermatitis)
  11. Have known positive serologic findings for human immunodeficiency virus (HIV) antibodies. Local laws and regulations may apply to whether testing is required.
  12. Has previous MRI evidence of significant abnormality that would suggest another potential etiology for progressive dementia or a clinically significant finding that may impact the patient's ability to safely participate in the study;
  13. Have any contraindications for MRI, including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker;
  14. Have any clinically important abnormality at screening, as determined by investigator, in physical or neurological examination, vital signs, ECG, or clinical laboratory test results that could be detrimental to the patient, could compromise the study, or show evidence of other etiologies for dementia.
  15. Has hypersensitivity to flortaucipir F 18 or any of its excipients;
  16. Intend to use drugs known to significantly prolong the QT interval within 14 days or 5 half-lives, whichever is longer, of a scheduled screening/baseline flortaucipir F 18 PET scan, or have medical history of risk factors for torsades de pointes.
  17. Have an ECG corrected QT (QTcF) interval measurement >450 msec (men) or >470 msec (women) at screening (as determined at the investigational site).
  18. Have poor venous access;
  19. Contraindication to PET;
  20. Present or planned exposure to ionizing radiation that, in combination with the planned administration of study PET ligands, would result in a cumulative exposure that exceeds local recommended exposure limits;
  21. Patients that are currently enrolled in any other interventional clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
  22. Have participated, within the last 30 days in a clinical trial involving an investigational product. If the previous investigational product is scientifically or medically incompatible with this study and has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed prior to screening (Participation in observational studies may be permitted upon review of the observational study protocol and approval by the sponsor).
  23. Are investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as spouse, parent, child, or sibling whether biological or legally adopted;
  24. Are Lilly employees or are employees of third-party organizations (TPOs) involved in a study that requires exclusion of their employees;
  25. In the opinion of the investigator, are otherwise unsuitable for a study of this type.
  26. Have received treatment with a stable dose of an acetylcholinesterase inhibitor (AChEI) and/or memantine for less than 1 months [If a patient has recently stopped an AChEI and/or memantine, he or she must have discontinued treatment at least 1 months prior].
  27. Have changes in concomitant medications that could potentially affect cognition and their dosing should be stable for at least 1 month before screening, (does not apply to medications with limited duration of use, such as antibiotics).
  28. Have received active immunization agents for the treatment of Alzheimer's Disease
  29. Have known allergies to LY3303560, related compounds, or any components of the formulation; or history of significant atopy
  30. Have allergies to either monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone;
  31. Are receiving IgG therapy (also known as gamma globulin or intravenous immunoglobulin [IVIG])

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03467477


Contacts
Contact: Avid Clinical Operations 215-298-0700 clinicaloperations@avidrp.com

Locations
United States, California
Irvine Center for Clinical Research Recruiting
Irvine, California, United States, 92614
Contact    949-753-1663      
Principal Investigator: Elly Lee, MD         
United States, Florida
Brain Matters Research Recruiting
Delray Beach, Florida, United States, 33445
Contact    561-734-8461 ext 103      
Principal Investigator: Mark Broday, MD         
Neuropsychiatric Research Center of Southwest Florida Recruiting
Fort Myers, Florida, United States, 33912
Contact    239-939-7777      
Principal Investigator: Wendy Robinson Bond, MD         
Renstar Medical Research Recruiting
Ocala, Florida, United States, 34470
Contact    352-629-5800      
Principal Investigator: John Paul Nardandrea, MD         
BioClinica Research Recruiting
Orlando, Florida, United States, 32806
Contact    407-426-9299 ext 377      
Principal Investigator: Esteban Olivera, MD         
Progressive Medical Research Recruiting
Port Orange, Florida, United States, 32127
Contact    386-304-7070 ext 3370      
Principal Investigator: Alexander White, MD         
United States, Illinois
Great Lakes Clinical Trials Recruiting
Chicago, Illinois, United States, 60640
Contact    773-275-3500      
Principal Investigator: Jeffrey Ross, MD         
United States, Kansas
Cotton O'neil Clinical Research Center Recruiting
Topeka, Kansas, United States, 66606
Contact    785-368-0745      
Principal Investigator: Michael Cox, MD         
United States, Rhode Island
Butler Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact    401-455-6403      
Principal Investigator: Stephen Salloway, MD         
Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
Study Chair: Chief Medical Officer Avid Radiopharmaceuticals

Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT03467477     History of Changes
Other Study ID Numbers: 18F-AV-1451-A24
First Posted: March 16, 2018    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders