Tau Screening Study in Subjects With Early Symptomatic AD

NCT03467477 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 18F-AV-1451-A24
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 9

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

• Flortaucipir Qualitative Results (Visual Reads)

  Flortaucipir PET scans were rated visually by an expert reader as follows: Not consistent with an AD pattern (τAD-), Moderate AD pattern (τAD+), or Advanced AD pattern and likely to progress (τAD++). Eligibility for future studies was determined from the flortaucipir PET scan according to protocol-specified criteria.

  baseline scan

• Flortaucipir Quantitative Results (SUVr)

  Flortaucipir standardized uptake value ratio (SUVr). A value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. Visual read categories as described for previous measure.

  baseline scan

Study Arms (1)

Flortaucipir PET Scan

EXPERIMENTAL

Drug: Flortaucipir F18; Procedure: Brain PET Scan

Interventions

Flortaucipir F18 DRUG

370 megabecquerel (MBq) IV single-dose

Also known as: 18F-AV-1451, [F-18]T807, LY3191748

Flortaucipir PET Scan

Brain PET Scan PROCEDURE

positron emission tomography (PET) scan of the brain

Flortaucipir PET Scan

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with gradual and progressive change in memory function reported by the patient or informant for ≥6 months
• Patients who have a mini-mental status exam (MMSE) score between 20-28 inclusive
• Patients who are willing to undergo a PET scan using flortaucipir F 18
• Patients who give informed consent or have a legally authorized representative (LAR) available to consent at the time of enrollment
• A study partner who must be available if the patient enters the treatment trial

You may not qualify if:

• 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 \[beta human chorionic gonadotropin\] 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;
• Patients who lack, in the investigator's opinion, adequate premorbid literacy, adequate vision, or adequate hearing to complete the required psychometric testing;
• Have significant neurological disease affecting the central nervous system (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);
• 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 \[Patients with history of schizophrenia or other chronic psychosis are excluded.\];
• 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;
• 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;
• Have a past history (suspected or confirmed) of Hepatitis B or Hepatitis C;
• Are clinically judged by the investigator to be at serious risk for suicide as assessed by medical history, examination, or the Columbia-Suicide Severity Rating Scale (C-SSRS).
• Have a history of alcohol or drug disorder (except tobacco use disorder) within 2 years before the screening visit;
• 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)
• Have known positive serologic findings for human immunodeficiency virus (HIV) antibodies. Local laws and regulations may apply to whether testing is required.
• 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;
• Have any contraindications for MRI, including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker;
• 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.
• Has hypersensitivity to flortaucipir F 18 or any of its excipients;

Sponsors & Collaborators

• Avid Radiopharmaceuticals: lead

Study Sites (9)

Irvine Center for Clinical Research

Irvine, California, 92614, United States

Location

Brain Matters Research

Delray Beach, Florida, 33445, United States

Location

Neuropsychiatric Research Center of Southwest Florida

Fort Myers, Florida, 33912, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

BioClinica Research

Orlando, Florida, 32806, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Great Lakes Clinical Trials

Chicago, Illinois, 60640, United States

Location

Cotton O'neil Clinical Research Center

Topeka, Kansas, 66606, United States

Location

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Medical Director
• Organization: Avid Radiopharmaceuticals, Inc.

clinicaloperations@avidrp.com

215-298-0700

Study Officials

• Chief Medical Officer

  Avid Radiopharmaceuticals

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 16, 2018
• Study Start: March 8, 2018
• Primary Completion: November 15, 2018
• Study Completion: November 15, 2018
• Last Updated: August 24, 2020
• Results First Posted: August 24, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)