Tau Screening Study in Patients With Early Symptomatic AD

NCT03322462 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 18F-AV-1451-A23
• Study Type: interventional
• Target: 155
• Locations: 2 countries
• Sites: 10

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 AACG study was determined from the flortaucipir PET scan quantitation (SUVr; see below) according to protocol-specified criteria that excluded subjects with tau PET signal that was above or below study 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. Eligibility for AACG study was determined from the flortaucipir PET scan quantitation (SUVr; see below) according to protocol-specified criteria that excluded subjects with tau PET signal that was above or below study criteria.

  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

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:

• Men or women between the ages of 60 and 85 years of age at the time of consent
• Patients with gradual and progressive change in memory function for a period equal to or greater than six months
• Patients who have a Mini Mental State Examination (MMSE) score in the 20-27 range
• 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) to consent for enrollment

You may not qualify if:

• Patients who lack adequate premorbid literacy, vision, or hearing to complete the required psychometric testing in the investigator's opinion
• Females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using reliable contraception methods. Females of childbearing potential must not be pregnant (negative serum β-Human Chorionic Gonadotropin \[HCG\] 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 flortaucipir F 18 injection administration.
• 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 types of dementia, serious brain infections, 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 opinion of the investigator, the disorder/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).
• 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 du Pointes.
• Have an average electrocardiography (ECG) corrected QT (QTcF) interval measurement \> 450 msec (men) or \> 470 msec (women) at screening (as determined at the investigational site).
• Have ocular pathology that significantly limits ability to reliably evaluate vision or the retina.
• Have a history of alcohol or drug disorder (except tobacco use disorder) within 2 years before the screening visit
• Have a current serious or unstable illness including retinal, 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 less than 24 months.
• Has a history of cancer within the last five years, with the exception of non-metastatic 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
• Patients with a past history (suspected or confirmed) of Hepatitis B or Hepatitis C
• History of vitiligo and/or current evidence of post-inflammatory hypopigmentation
• Have had prior treatment with a passive anti-amyloid immunotherapy less than five half-lives prior to randomization.
• Have previously participated in any other study investigating active immunization against amyloid beta (Aβ)
• 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

Sponsors & Collaborators

• Avid Radiopharmaceuticals: lead

Study Sites (10)

Pacific Research Network

San Diego, California, 92103, United States

Location

Syrentis Clinical Research

Santa Ana, California, 92705, United States

Location

Brain Matters Research

Delray Beach, Florida, 33445, United States

Location

Bioclinica (Compass Research)

Orlando, Florida, 32806, United States

Location

Axiom Clinical Research

Tampa, Florida, 33609, United States

Location

Boston Center for Memory

Newton, Massachusetts, 02459, United States

Location

PMG Research

Winston-Salem, North Carolina, 27103, United States

Location

Abington Neurological Associates

Willow Grove, Pennsylvania, 19090, United States

Location

The Memory Clinic

Bennington, Vermont, 05201, United States

Location

Toronto Memory Program

Toronto, Ontario, M3B 2S7, Canada

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, Inc.

  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: October 16, 2017
• First Posted: October 26, 2017
• Study Start: November 21, 2017
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: August 24, 2020
• Results First Posted: August 24, 2020

Record last verified: 2020-08

Locations

US (9); CA (1)