Alzheimer's DiseasePhase 2NCT02795780
Follow up 18F-AV-1451 Scan in Confirmatory Cohort Subjects From Study 18F-AV-1451-A05
A Phase 2 study testing Flortaucipir F18 and PET Scan in people with Alzheimer's Disease, run by Avid Radiopharmaceuticals at 22 sites in United States.
Trial summary
This study will evaluate longitudinal change of tau deposition as measured by flortaucipir F 18 uptake over time. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Flortaucipir F18 and PET Scan
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 22 sitesUnited States
- Study dates
- Aug 2016to 28 Aug 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmatory cohort subjects who completed the 18F-AV-1451-A05 (NCT02016560) study
Who cannot join
- Current clinically significant cardiovascular disease, ECG abnormalities, risk factors for Torsades de Pointes (TdP), or are taking drugs known to cause QT prolongation
- Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
- Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
- Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session
- Have received or participated in a trial with investigational medications in the past 30 days
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston University School of Medicine
Boston, Massachusetts, 02118
Duke University Medical Center
Durham, North Carolina, 27710
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912
Institute for Brain Aging and Dementia, UC Irvine
Irvine, California, 92697
Las Vegas Radiology
Las Vegas, Nevada, 89113
New York University Center for Brain Health
New York, New York, 10016
21st Century Oncology
Newport Beach, California, 92663
Compass Research, LLC
Orlando, Florida, 32806
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Banner Alzheimer's Institute
Phoenix, Arizona, 85006
Rhode Island Hospital
Providence, Rhode Island, 02903
Butler Hospital
Providence, Rhode Island, 02906
Alzheimer's Disease Center, UC Davis
Sacramento, California, 95817
California Medical Clinic for Headache
Santa Monica, California, 90404
Imaging Endpoints
Scottsdale, Arizona, 85258
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
Washington University School of Medicine
St Louis, Missouri, 63110
Meridien Research
St. Petersburg, Florida, 33709
Banner Sun Health Research Institute
Sun City, Arizona, 85351
University of South Florida Health Byrd Alzheimer's Institute
Tampa, Florida, 33613
Premiere Research Institute
West Palm Beach, Florida, 33407
About this study
Official title: An Open Label, Multicenter Study Evaluating the Imaging Characteristics of a Follow up 18F-AV-1451 Scan in Subjects That Participated in the Confirmatory Cohort of 18F-AV-1451-A05
This study will evaluate longitudinal change of tau deposition as measured by flortaucipir F 18 uptake over time.
- Conditions
- Alzheimer's Disease
- Being tested
- Flortaucipir F18, PET Scan
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flortaucipir F18Drug
Also called T807, 18F-AV-1451
370 megabecquerel (MBq) IV single-dose
PET ScanProcedure or surgery
positron emission tomography (PET) scan
| Study group | Role | What they receive |
|---|---|---|
| Follow-up Flortaucipir PET Scan | Experimental | Not described Receives: Drug: Flortaucipir F18; Procedure: PET Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tau Deposition Over Time by Diagnostic Group and Amyloid Status
Change in flortaucipir standardized uptake value ratio (SUVr) over 18 months. For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. A positive change in SUVr represents an increase in tau deposition in the brain. Change = 18 month SUVr - baseline SUVr obtained in Study A05.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startAug 2016
- Primary completion28 Aug 2017
- Study completion28 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avid Radiopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795780
- Sponsor's protocol ID
- 18F-AV-1451-A18
- Status last verified
- Aug 2020
- First submitted
- 7 Jun 2016
- Last updated
- 24 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multicenter Study Evaluating the Imaging Characteristics of a Follow up 18F-AV-1451 Scan in Subjects That Participated in the Confirmatory Cohort of 18F-AV-1451-A05
- ClinicalTrials.gov ID
- NCT02795780
- Acronym / sponsor ID
- 18F-AV-1451-A18
- Conditions
- Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- 28 Aug 2017 (actual)
- Study completion
- 28 Aug 2017 (actual)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Posted 24 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate longitudinal change of tau deposition as measured by flortaucipir F 18 uptake over time.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Follow-up Flortaucipir PET Scan | Experimental | Drug: Flortaucipir F18, Procedure: PET Scan |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Confirmatory cohort subjects who completed the 18F-AV-1451-A05 (NCT02016560) study
Key exclusion criteria (5 listed)
- Current clinically significant cardiovascular disease, ECG abnormalities, risk factors for Torsades de Pointes (TdP), or are taking drugs known to cause QT prolongation
- Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
- Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
- Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session
- Have received or participated in a trial with investigational medications in the past 30 days
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 |
|---|---|---|
| Flortaucipir F18Also: T807, 18F-AV-1451370 megabecquerel (MBq) IV single-dose | Drug | Follow-up Flortaucipir PET Scan |
| PET Scanpositron emission tomography (PET) scan | Procedure or surgery | Follow-up Flortaucipir PET Scan |
Primary outcome
Change in Tau Deposition Over Time by Diagnostic Group and Amyloid Status
Time frame: 18 months
Change in flortaucipir standardized uptake value ratio (SUVr) over 18 months. For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. A positive change in SUVr represents an increase in tau deposition in the brain. Change = 18 month SUVr - baseline SUVr obtained in Study A05.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Alzheimer's Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Flortaucipir F18 and PET Scan in people with Alzheimer's Disease, run by Avid Radiopharmaceuticals at 22 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 1 inclusion and 5 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 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Tau Deposition Over Time by Diagnostic Group and Amyloid Status (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2020.