18F-AV-1451 PET Imaging in Participants Enrolled in the LEARN Study

NCT02850146 | Completed Phase 1 DMC

• 2 other identifiers: 18F-AV-1451-A1715-338729
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 7

Brief Summary

Approximately 50 participants enrolled in the LEARN study (NCT02488720) will be enrolled in the LEARN-Tau study. The study designed to evaluate the imaging characteristics of 18F-AV-1451 in participants enrolled in the LEARN study and to expand the safety database of 18F-AV-1451. The study will run in parallel to the LEARN study. In this study, participants will undergo up to four (4) 18F-AV-1451 PET scans over a 4.5 year period. Imaging visits will occur at the throughout the participant's participation in the LEARN study (corresponding to LEARN Visit 1, between Visit 4 and 6, Visit 8, and Visit 11). The LEARN-Tau study will (1) look at change in the amount of tau protein in the brain over time, measured by the 18F-AV-1451 PET scan, (2) see if tau protein in the brain of older individuals is associated with memory problems and (3) evaluate the safety of 18F-AV-1451 and any side effects that might be associated with it. Site investigators, participants, and study partners will not be informed of the results of the 18F-AV-1451 PET scan results as they relate to the study; however, any findings that may be of potential medical concern will be provided for appropriate follow-up.

Conditions

Cognition Disorders

Keywords

tau; cognition; longitudinal; cognitive decline; observational; imaging

Outcome Measures

Primary Outcomes (2)

• Rate of change of tau deposition as measured by 18F-AV-1451

  3 years

• Change in tau deposition as measured by 18F-AV-1451 standardized uptake value ratio (SUVR) from the baseline scan

  Baseline, 84 weeks, 168 weeks

Study Arms (1)

18F-AV-1451

EXPERIMENTAL

50 individuals who are cognitively normal, older, Aβ not elevated and enrolled in the LEARN study will undergo 18F-AV-1451 imaging procedures at 4 time points over a 4.5 year period.

Drug: 18F-AV-1451

Interventions

18F-AV-1451 DRUG

18F-AV-1451

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may not qualify if:

• Male or female that have consented and are currently enrolled in the LEARN protocol;
• Participants who sign an IRB approved informed consent form prior to any study procedure; and
• Participants who in the opinion of the investigator can tolerate the PET scan procedures.
• Has any condition that, in the investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the experimental procedures, or interfere with analysis of the data. (For example, participants with chronic back pain might not be able to lie still during the scanning procedures.);
• Has abnormal findings on physical examination or laboratory screening tests that suggest the participant might have a condition that could, in the opinion of the investigator, affect his or her response to the radiopharmaceutical and related testing procedures;
• Is deemed likely to be unable to perform all of the imaging procedures for any reason;
• Has a history of risk factors for torsades de pointes, including clinically significant findings on ECG, or is taking medications known to prolong QT interval such as citalopram ≥ 40 mg/day, disopyramide, dofetilide, ibutilide, procainamide, quinidine, sotalol, or bepridil; A list of restricted medications will be provided.
• Are females of childbearing potential (extremely unlikely in the LEARN eligible population ages 65 to 85) 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 or urine β-hCG at the time of screening and negative serum or urine β-hCG on imaging day) or breastfeeding at screening. Females must agree to avoid becoming pregnant, and both females and males must agree to refrain from sexual activity or to use reliable contraceptive methods for 24 hours following administration of 18F-AV-1451 Injection; Males with female partners who are pregnant or of childbearing potential must agree to refrain from sexual activity for 24 hours following administration of 18F-AV-1451 Injection. Additionally, males must agree not to donate sperm for 24 hours following administration of 18F-AV-1451 Injection;
• Has hypersensitivity to 18F-AV-1451 or any of its excipients.

Sponsors & Collaborators

• University of Southern California: lead
• Alzheimer's Therapeutic Research Institute: collaborator
• Alzheimer's Association: collaborator
• Avid Radiopharmaceuticals: collaborator

Study Sites (7)

Banner Alzheimer's Institute

Phoenix, Arizona, 85006, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Bioclinica Research North

The Villages, Florida, 32162, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Rochester Medical Center

Rochester, New York, 14620, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Butler Hospital Memory and Aging Program

Providence, Rhode Island, 02906, United States

Location

Related Publications (4)

• Chien DT, Bahri S, Szardenings AK, Walsh JC, Mu F, Su MY, Shankle WR, Elizarov A, Kolb HC. Early clinical PET imaging results with the novel PHF-tau radioligand [F-18]-T807. J Alzheimers Dis. 2013;34(2):457-68. doi: 10.3233/JAD-122059.

  PMID: 23234879 BACKGROUND

• Duyckaerts C, Brion JP, Hauw JJ, Flament-Durand J. Quantitative assessment of the density of neurofibrillary tangles and senile plaques in senile dementia of the Alzheimer type. Comparison of immunocytochemistry with a specific antibody and Bodian's protargol method. Acta Neuropathol. 1987;73(2):167-70. doi: 10.1007/BF00693783.

  PMID: 2440224 BACKGROUND

• Nelson PT, Alafuzoff I, Bigio EH, Bouras C, Braak H, Cairns NJ, Castellani RJ, Crain BJ, Davies P, Del Tredici K, Duyckaerts C, Frosch MP, Haroutunian V, Hof PR, Hulette CM, Hyman BT, Iwatsubo T, Jellinger KA, Jicha GA, Kovari E, Kukull WA, Leverenz JB, Love S, Mackenzie IR, Mann DM, Masliah E, McKee AC, Montine TJ, Morris JC, Schneider JA, Sonnen JA, Thal DR, Trojanowski JQ, Troncoso JC, Wisniewski T, Woltjer RL, Beach TG. Correlation of Alzheimer disease neuropathologic changes with cognitive status: a review of the literature. J Neuropathol Exp Neurol. 2012 May;71(5):362-81. doi: 10.1097/NEN.0b013e31825018f7.

  PMID: 22487856 BACKGROUND

• Xia CF, Arteaga J, Chen G, Gangadharmath U, Gomez LF, Kasi D, Lam C, Liang Q, Liu C, Mocharla VP, Mu F, Sinha A, Su H, Szardenings AK, Walsh JC, Wang E, Yu C, Zhang W, Zhao T, Kolb HC. [(18)F]T807, a novel tau positron emission tomography imaging agent for Alzheimer's disease. Alzheimers Dement. 2013 Nov;9(6):666-76. doi: 10.1016/j.jalz.2012.11.008. Epub 2013 Feb 12.

  PMID: 23411393 BACKGROUND

Related Links

• Alzheimer's Therapeutic Research Institute
• Alzheimer's Association
• Avid Radiopharmaceuticals

MeSH Terms

Conditions

Cognition Disorders; Pick Disease of the Brain; Cognitive Dysfunction

Interventions

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

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders; Frontotemporal Dementia; Frontotemporal Lobar Degeneration; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Reisa Sperling, MD

  Center for Alzheimer Research and Treatment Brigham and Women's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Alzheimer's Therapeutic Research Institute

Study Record Dates

• First Submitted: July 27, 2016
• First Posted: July 29, 2016
• Study Start: August 1, 2016
• Primary Completion: September 29, 2023
• Study Completion: September 29, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

US (7)