Cognition DisordersPhase 1LEARN-TauNCT02850146
18F-AV-1451 PET Imaging in Participants Enrolled in the LEARN Study
A Phase 1 study testing 18F-AV-1451 in people with Cognition Disorders, run by University of Southern California at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition Disorders
- What is being tested?
- 18F-AV-1451
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2016to 29 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Yale University School of Medicine
New Haven, Connecticut, 06510
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Banner Alzheimer's Institute
Phoenix, Arizona, 85006
Butler Hospital Memory and Aging Program
Providence, Rhode Island, 02906
University of Rochester Medical Center
Rochester, New York, 14620
Bioclinica Research North
The Villages, Florida, 32162
About this study
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).
Read more
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
- Being tested
- 18F-AV-1451
- Keywords
- tau, cognition, longitudinal, cognitive decline, observational, imaging
- Medical subject headings
- Cognition Disorders, Pick Disease of the Brain, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-AV-1451Drug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 18F-AV-1451 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change of tau deposition as measured by 18F-AV-1451
Measured: 3 years
Change in tau deposition as measured by 18F-AV-1451 standardized uptake value ratio (SUVR) from the baseline scan
Measured: Baseline, 84 weeks, 168 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startAug 2016
- Primary completion29 Sep 2023
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cognition DisordersStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Therapeutic Research Institute, Alzheimer's Association, Avid Radiopharmaceuticals
- Responsible party
- Principal investigator, Paul Aisen, University of Southern California
- Investigators
- Reisa Sperling, MD, Study director, Center for Alzheimer Research and Treatment Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850146
- Sponsor's protocol ID
- 18F-AV-1451-A17
- Other IDs
- 15-338729
- Acronym
- LEARN-Tau
- Status last verified
- Nov 2023
- First submitted
- 27 Jul 2016
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 23234879Duyckaerts 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.
PubMed 2440224Nelson 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.
PubMed 22487856Xia 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.
PubMed 23411393
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-AV-1451 PET Imaging in Participants Enrolled in the LEARN Study
- ClinicalTrials.gov ID
- NCT02850146
- Acronym / sponsor ID
- LEARN-Tau / 18F-AV-1451-A17
- Conditions
- Cognition Disorders
- Keywords
- tau, cognition, longitudinal, cognitive decline, observational, imaging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Alzheimer's Therapeutic Research Institute, Alzheimer's Association, Avid Radiopharmaceuticals
- Study start
- Aug 2016
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 29 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-AV-1451 | Experimental | Drug: 18F-AV-145150 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-AV-1451 | Drug | 18F-AV-1451 |
Primary outcome
Rate of change of tau deposition as measured by 18F-AV-1451
Time frame: 3 years
Change in tau deposition as measured by 18F-AV-1451 standardized uptake value ratio (SUVR) from the baseline scan
Time frame: Baseline, 84 weeks, 168 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 23234879Chien 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.
- Background: PubMed 2440224Duyckaerts 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.
- Background: PubMed 22487856Nelson 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.
- Background: PubMed 23411393Xia 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.
- Alzheimer's Therapeutic Research InstituteLink provided by the sponsor.
- Alzheimer's AssociationLink provided by the sponsor.
- Avid RadiopharmaceuticalsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reisa Sperling, MD study director
Center for Alzheimer Research and Treatment Brigham and Women's Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 18F-AV-1451 in people with Cognition Disorders, run by University of Southern California at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of change of tau deposition as measured by 18F-AV-1451 (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02850146, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.