Alzheimer's DiseasePhase 2/3MCINCT02016560

Analysis of 18F-AV-1451 PET Imaging in Cognitively Healthy, MCI, and AD Subjects

A Phase 2/3 study testing florbetapir F 18, Flortaucipir F18 and Brain PET Scan in people with Alzheimer's Disease, run by Avid Radiopharmaceuticals at 27 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

A Phase 2/3 cross-sectional and longitudinal observational study evaluating imaging characteristics of flortaucipir in control subjects and patients with clinically defined MCI and AD dementia (AD). Read more about this study

Who is it for?: Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for: Alzheimer's Disease
What is being tested?: florbetapir F 18, Flortaucipir F18 and Brain 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: 383 participants
Where: 27 sitesUnited States
Study dates: Dec 2013to 28 Jul 2017
Phase: Phase 2/3
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 20 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Exploratory Cognitively Healthy Subjects
≥ 20 to ≤ 40 years of age OR ≥ 50 years of age
Mini-mental state examination (MMSE) ≥ 29
No significant history of cognitive impairment
Exploratory MCI Subjects
≥ 50 years of age

Show all 19Show fewer

MMSE ≥ 24
Have MCI consistent with National Institute on Aging-Alzheimer's Association (NIA-AA) working group's diagnostic guidelines for AD
Have a study partner that can report on subject's activities of daily living
Exploratory AD Subjects
≥ 50 years of age
MMSE > 10
Have possible or probable AD based on the NIA-AA working group's diagnostic guidelines for AD
Have a study partner that can report on subject's activities of daily living
Confirmatory Subjects
≥ 50 years of age
MMSE ≥ 20 and ≤ 27
Cognitively impaired subjects with either MCI or dementia with a suspected neurodegenerative cause
Have a study partner that can report on subject's activities of daily living

Who cannot join

Current clinically significant psychiatric disease
Evidence of structural brain abnormalities
History of moderate or severe traumatic brain injury
Current clinically significant cardiovascular disease or ECG abnormalities, or additional risk factors for Torsades de Pointes
Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
History of alcohol or substance abuse or dependence

Show all 9Show fewer

Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
Have received or participated in a trial with investigational medications in the past 30 days
Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session.

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

United States27 sites

Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston University
Boston, Massachusetts, 02118
Quantum Laboratories
Deerfield Beach, Florida, 33064
Duke University Medical Center
Durham, North Carolina, 27710
21st Century Oncology
Fort Myers, Florida, 33912
UC Irvine
Irvine, California, 92697
Las Vegas Radiology
Las Vegas, Nevada, 89147
Molecular NeuroImaging
New Haven, Connecticut, 06510
Center for Brain Health - NYU Langone Medical Center
New York, New York, 10016
Hoag Memorial
Newport Beach, California, 92663
Sandlake Imaging
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
Quincy, Massachusetts, 02169
Norther California PET Imaging Center
Sacramento, California, 95816
UC Davis
Sacramento, California, 95817
UC San Francisco
San Francisco, California, 94158
Neurological Research Institute
Santa Monica, California, 90404
Four Peaks Neurology
Scottsdale, Arizona, 85258
Mayo Clinic
Scottsdale, Arizona, 85259
Center for Clinical Imaging Research
St Louis, Missouri, 63110
Meridien Research
St. Petersburg, Florida, 33709
Banner Sun Health Research Institute
Sun City, Arizona, 85351
USF Health Byrd Alzheimer's Center
Tampa, Florida, 33613
Independent Imaging
West Palm Beach, Florida, 33407

Other trials in United States

About this study

Official title: An Open Label, Multicenter Study, Evaluating the Safety and Imaging Characteristics of 18F-AV-1451 in Cognitively Healthy Volunteers, Subjects With Mild Cognitive Impairment, and Subjects With Alzheimer's Disease

A Phase 2/3 cross-sectional and longitudinal observational study evaluating imaging characteristics of flortaucipir in control subjects and patients with clinically defined MCI and AD dementia (AD).

Read the detailed description

This study was conducted in 2 phases: a Phase 2 Exploratory Phase and a Phase 3 Confirmatory Phase. An overarching goal of the Exploratory Phase of this protocol was to further investigate the pattern of flortaucipir PET imaging across the disease course, in cognitively healthy subjects through patients with cognitive decline. To accomplish this goal, the protocol investigated flortaucipir results in younger and older cognitively healthy normal volunteers and patients with clinical diagnoses for cognitive complaints, ranging from MCI to mild and moderate AD dementia. Additionally, the Exploratory Phase of this protocol investigated relationships between flortaucipir PET signal and cognitive decline over the 18-month study period.

The second, Confirmatory Phase of the study was designed to provide independent validation of the relationships observed in the exploratory analyses of the first phase. In particular, the goal of the second phase was to confirm the relationship between flortaucipir uptake in the brain as measured by PET signals at baseline and the subsequent rate of cognitive decline observed over the 18-month longitudinal follow up.

Conditions: Alzheimer's Disease
Being tested: florbetapir F 18, Flortaucipir F18, Brain 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.

florbetapir F 18Drug
Also called Amyvid, 18F-AV-45
Flortaucipir F18Drug
Also called T807, 18F-AV-1451
Brain PET ScanProcedure or surgery
positron emission tomography (PET) scan of the brain

Study groups in NCT02016560
Study group	Role	What they receive
Exploratory Cognitively Healthy Subjects	Experimental	Subjects will receive an IV injection, 370 megabecquerel (MBq) (10 millicurie [mCi]), single dose of florbetapir F 18 at baseline. Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of flortaucipir at baseline. Receives: Drug: florbetapir F 18; Drug: Flortaucipir F18; Procedure: Brain PET Scan
Exploratory MCI Subjects	Experimental	Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of florbetapir F 18 at baseline. Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of flortaucipir at baseline, 9 months and 18 months. Receives: Drug: florbetapir F 18; Drug: Flortaucipir F18; Procedure: Brain PET Scan
Exploratory AD Subjects	Experimental	Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of florbetapir F 18 at baseline. Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of flortaucipir at baseline, 9 months and 18 months. Receives: Drug: florbetapir F 18; Drug: Flortaucipir F18; Procedure: Brain PET Scan
Confirmatory Subjects	Experimental	Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of florbetapir F 18 and flortaucipir at baseline. Receives: Drug: florbetapir F 18; Drug: Flortaucipir F18; Procedure: Brain PET Scan

What is being measured

The primary outcome is the main question the study is designed to answer.

Confirmatory Phase: Relationship Between Neocortical Flortaucipir Uptake and the Subsequent Rate of Cognitive Decline
Confirm the relationship between neocortical flortaucipir uptake and the subsequent rate of cognitive decline at longitudinal follow up that was observed in the Exploratory Phase of the study. Patients were assigned to groups by majority classification of the flortaucipir positron emission tomography (PET) scan by five independent imaging physicians. Clinically meaningful cognitive and functional deterioration was defined as a 1 point or greater worsening on clinical dementia rating - sum of boxes (CDR-SB) score over the follow-up period.
Measured: between baseline and 18 months
Exploratory Phase: Cross-sectional Flortaucipir Imaging Results
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.
Measured: baseline scan
Exploratory Phase: Longitudinal Change in Tau Deposition Over Time, by Amyloid Status
Assess the rate of change of tau deposition as measured by flortaucipir uptake (SUVr) over time. Change = 18 months SUVr - baseline SUVr.
Measured: baseline and 18 months

Secondary outcomes (2)

Confirmatory Phase: Diagnostic Performance of Flortaucipir Visual Read
This analysis used dichotomized CDR-SB change as a truth standard (1 point or more worsening = true positive vs. less than 1 point worsening = true negative) to assess the diagnostic performance of baseline Advanced AD tau status (τAD++) as determined by flortaucipir scan interpretation. Sensitivity and Specificity were calculated for each of the 5 independent imaging readers. Sensitivity is the percentage of true positive cases correctly identified by an Advanced AD pattern scan. Specificity is the percentage of true negative cases correctly identified by scans that were not classified as Advanced AD pattern.
Measured: baseline and 18 months
Exploratory Phase: Correlation Between Flortaucipir SUVr and Age
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.
Measured: baseline scan

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 201328 Jul 2017

First posted20 Dec 2013 (estimated)
Study startDec 2013
Primary completion28 Jul 2017
Study completion28 Jul 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.
Publications (1)Papers the sponsor has linked to this study.
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 2/3
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Sequential
Model description: All subjects in both the exploratory and confirmatory phases of the study, receive both florbetapir and florbetapir scans, regardless of subgroup assignment.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 383 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02016560
Sponsor's protocol ID: 18F-AV-1451-A05
Acronym: MCI
Status last verified: Sep 2020
First submitted: 16 Dec 2013
Last updated: 22 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Lu M, Pontecorvo MJ, Devous MD Sr, Arora AK, Galante N, McGeehan A, Devadanam C, Salloway SP, Doraiswamy PM, Curtis C, Truocchio SP, Flitter M, Locascio T, Devine M, Zimmer JA, Fleisher AS, Mintun MA; AVID Collaborators. Aggregated Tau Measured by Visual Interpretation of Flortaucipir Positron Emission Tomography and the Associated Risk of Clinical Progression of Mild Cognitive Impairment and Alzheimer Disease: Results From 2 Phase III Clinical Trials. JAMA Neurol. 2021 Apr 1;78(4):445-453. doi: 10.1001/jamaneurol.2020.5505.
PubMed 33587110

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Multicenter Study, Evaluating the Safety and Imaging Characteristics of 18F-AV-1451 in Cognitively Healthy Volunteers, Subjects With Mild Cognitive Impairment, and Subjects With Alzheimer's Disease
ClinicalTrials.gov ID: NCT02016560
Acronym / sponsor ID: MCI / 18F-AV-1451-A05
Conditions: Alzheimer's Disease
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 383 participants (actual)
Lead sponsor: Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Dec 2013 (actual)
Primary completion: 28 Jul 2017 (actual)
Study completion: 28 Jul 2017 (actual)
First posted: 20 Dec 2013 (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.

A Phase 2/3 cross-sectional and longitudinal observational study evaluating imaging characteristics of flortaucipir in control subjects and patients with clinically defined MCI and AD dementia (AD).

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Sequential
Masking: Single blind (outcomes assessor)
Number of arms: 4
Model description: All subjects in both the exploratory and confirmatory phases of the study, receive both florbetapir and florbetapir scans, regardless of subgroup assignment.

Arm	Type	Receives
Exploratory Cognitively Healthy Subjects	Experimental	Drug: florbetapir F 18, Drug: Flortaucipir F18, Procedure: Brain PET ScanSubjects will receive an IV injection, 370 megabecquerel (MBq) (10 millicurie [mCi]), single dose of florbetapir F 18 at baseline. Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of flortaucipir at baseline.
Exploratory MCI Subjects	Experimental	Drug: florbetapir F 18, Drug: Flortaucipir F18, Procedure: Brain PET ScanSubjects will receive an IV injection, 370 MBq (10 mCi), single dose of florbetapir F 18 at baseline. Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of flortaucipir at baseline, 9 months and 18 months.
Exploratory AD Subjects	Experimental	Drug: florbetapir F 18, Drug: Flortaucipir F18, Procedure: Brain PET ScanSubjects will receive an IV injection, 370 MBq (10 mCi), single dose of florbetapir F 18 at baseline. Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of flortaucipir at baseline, 9 months and 18 months.
Confirmatory Subjects	Experimental	Drug: florbetapir F 18, Drug: Flortaucipir F18, Procedure: Brain PET ScanSubjects will receive an IV injection, 370 MBq (10 mCi), single dose of florbetapir F 18 and flortaucipir at baseline.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

Exploratory Cognitively Healthy Subjects
≥ 20 to ≤ 40 years of age OR ≥ 50 years of age
Mini-mental state examination (MMSE) ≥ 29
No significant history of cognitive impairment
Exploratory MCI Subjects

Key exclusion criteria (9 listed)

Current clinically significant psychiatric disease
Evidence of structural brain abnormalities
History of moderate or severe traumatic brain injury
Current clinically significant cardiovascular disease or ECG abnormalities, or additional risk factors for Torsades de Pointes
Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer

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
florbetapir F 18Also: Amyvid, 18F-AV-45	Drug	Confirmatory Subjects, Exploratory AD Subjects, Exploratory Cognitively Healthy Subjects, Exploratory MCI Subjects
Flortaucipir F18Also: T807, 18F-AV-1451	Drug	Confirmatory Subjects, Exploratory AD Subjects, Exploratory Cognitively Healthy Subjects, Exploratory MCI Subjects
Brain PET Scanpositron emission tomography (PET) scan of the brain	Procedure or surgery	Confirmatory Subjects, Exploratory AD Subjects, Exploratory Cognitively Healthy Subjects, Exploratory MCI Subjects

Primary outcome

Confirmatory Phase: Relationship Between Neocortical Flortaucipir Uptake and the Subsequent Rate of Cognitive Decline
Time frame: between baseline and 18 months
Confirm the relationship between neocortical flortaucipir uptake and the subsequent rate of cognitive decline at longitudinal follow up that was observed in the Exploratory Phase of the study. Patients were assigned to groups by majority classification of the flortaucipir positron emission tomography (PET) scan by five independent imaging physicians. Clinically meaningful cognitive and functional deterioration was defined as a 1 point or greater worsening on clinical dementia rating - sum of boxes (CDR-SB) score over the follow-up period.
Exploratory Phase: Cross-sectional Flortaucipir Imaging Results
Time frame: baseline scan
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.
Exploratory Phase: Longitudinal Change in Tau Deposition Over Time, by Amyloid Status
Time frame: baseline and 18 months
Assess the rate of change of tau deposition as measured by flortaucipir uptake (SUVr) over time. Change = 18 months SUVr - baseline SUVr.

2 secondary outcomes

Confirmatory Phase: Diagnostic Performance of Flortaucipir Visual Read
Time frame: baseline and 18 months
Exploratory Phase: Correlation Between Flortaucipir SUVr and Age
Time frame: baseline scan

Results and safety

Results posted to the registry on 24 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exploratory Young Cognitively Healthy Subjects	16	16
Exploratory Older Cognitively Healthy Subjects	58	54
Exploratory MCI Subjects	98	62
Exploratory AD Subjects	51	35
Confirmatory Subjects MCI	0	0
Confirmatory Subjects AD	0	0

Primary outcome: Confirmatory Phase: Relationship Between Neocortical Flortaucipir Uptake and the Subsequent Rate of Cognitive Decline

Time frame: between baseline and 18 months. Count of participants. Unit: Participants

Measure	Predicted to Progress n = 63	Not Predicted to Progress n = 68
Clinically meaningful progression	36	31
Did Not Progress	27	37

Predicted to Progress vs Not Predicted to Progress: Cox Proportional Hazard: 1.581 (95% CI 0.968 to 2.581), p = 0.067, Cox proportional hazards

Population analysed: Subjects from the confirmatory phase with valid flortaucipir visual read and 9 or 18 month clinical follow-up.

Primary outcome: Exploratory Phase: Cross-sectional Flortaucipir Imaging Results

Time frame: baseline scan. Least squares mean (Standard Error). Unit: standardized uptake value ratio (SUVr)

Measure	Exploratory AD Subjects n = 48	Exploratory MCI Subjects n = 97	Exploratory Older Cognitively Healthy Subjects n = 57	Exploratory Young Cognitively Healthy Subjects n = 16
Aβ+ SUVr	1.53 (0.037)	1.26 (0.030)	1.08 (0.093)	–
Aβ- SUVr	1.03 (0.051)	0.99 (0.029)	0.98 (0.029)	1.01 (0.039)

Exploratory AD Subjects vs Exploratory Older Cognitively Healthy Subjects: p <0.0001, ANCOVA
Exploratory MCI Subjects vs Exploratory Older Cognitively Healthy Subjects: p = 0.0622, ANCOVA
Exploratory AD Subjects vs Exploratory MCI Subjects: p <0.0001, ANCOVA

Population analysed: Analysis included all subjects who received an injection of flortaucipir, had valid quantifiable flortaucipir imaging data available, and valid quantifiable florbetapir PET data.

Primary outcome: Exploratory Phase: Longitudinal Change in Tau Deposition Over Time, by Amyloid Status

Time frame: baseline and 18 months. Least squares mean (Standard Error). Unit: standardized uptake value ratio (SUVr)

Measure	Exploratory AB+ (Amyloid Beta Positive) n = 55	Exploratory AB- (Amyloid Beta Negative) n = 90
Value	0.052359 (0.008536)	0.000655 (0.002394)

Exploratory AB+ (Amyloid Beta Positive): p <0.0001, Mixed Models Analysis
Exploratory AB- (Amyloid Beta Negative): p = 0.7851, Mixed Models Analysis

Population analysed: Analysis of flortaucipir SUVr Change Over Time by Amyloid Status, Exploratory Phase Efficacy Population (AD and MCI subjects only)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.. Other adverse events reported at 0.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exploratory Younger Cognitively Healthy Subjects	0 of 16 (0%)	3 of 16 (18.8%)	0 of 16
Exploratory Older Cognitively Healthy Subjects	0 of 58 (0%)	17 of 58 (29.3%)	0 of 58
Exploratory MCI Subjects	1 of 98 (1%)	21 of 98 (21.4%)	0 of 98
Exploratory AD Subjects	0 of 51 (0%)	13 of 51 (25.5%)	0 of 51
Confirmatory Subjects MCI	0 of 98 (0%)	13 of 98 (13.3%)	0 of 98
Confirmatory Subjects AD	0 of 62 (0%)	0 of 62 (0%)	0 of 62

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33587110Lu M, Pontecorvo MJ, Devous MD Sr, Arora AK, Galante N, McGeehan A, Devadanam C, Salloway SP, Doraiswamy PM, Curtis C, Truocchio SP, Flitter M, Locascio T, Devine M, Zimmer JA, Fleisher AS, Mintun MA; AVID Collaborators. Aggregated Tau Measured by Visual Interpretation of Flortaucipir Positron Emission Tomography and the Associated Risk of Clinical Progression of Mild Cognitive Impairment and Alzheimer Disease: Results From 2 Phase III Clinical Trials. JAMA Neurol. 2021 Apr 1;78(4):445-453. doi: 10.1001/jamaneurol.2020.5505.

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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.

The record lists no contact. Use the official record to reach the sponsor.

27 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing florbetapir F 18, Flortaucipir F18 and Brain PET Scan in people with Alzheimer's Disease, run by Avid Radiopharmaceuticals at 27 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 19 inclusion and 9 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 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Confirmatory Phase: Relationship Between Neocortical Flortaucipir Uptake and the Subsequent Rate of Cognitive Decline (time frame: between baseline and 18 months). The study lists 3 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 NCT02016560, which also lists 1 linked publication.

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 22 Sep 2020.