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

Cognition Disorders Clinical Trial

— LEARN-Tau  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02850146
• Other study ID #: 18F-AV-1451-A17
• Secondary ID: 15-338729
• Status: Completed
• Phase: Phase 1
• Start date: August 2016
• Est. completion date: September 29, 2023

Study information

• Verified date: November 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 29, 2023
• Est. primary completion date: September 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

Participants should meet inclusion and exclusion criteria for the LEARN study, and in addition:

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 ß-hCG at the time of screening and negative serum or urine ß-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.

Related Conditions & MeSH terms

• Cognition Disorders

Intervention

Drug:
• 18F-AV-1451

Locations

Country	Name	City	State
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Yale University School of Medicine	New Haven	Connecticut
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Banner Alzheimer's Institute	Phoenix	Arizona
United States	Butler Hospital Memory and Aging Program	Providence	Rhode Island
United States	University of Rochester Medical Center	Rochester	New York
United States	Bioclinica Research North	The Villages	Florida

Sponsors (4)

Lead Sponsor	Collaborator
University of Southern California	Alzheimer's Association, Alzheimer's Therapeutic Research Institute, Avid Radiopharmaceuticals

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of change of tau deposition as measured by 18F-AV-1451		3 years
Primary	Change in tau deposition as measured by 18F-AV-1451 standardized uptake value ratio (SUVR) from the baseline scan		Baseline, 84 weeks, 168 weeks

External Links

•   Alzheimer's Association
•   Alzheimer's Therapeutic Research Institute
•   Avid Radiopharmaceuticals
•   National Institute on Aging