Cognitive ImpairmentPhase 2NCT03618186
Neuroimaging Study
A Phase 2 study testing Tau PET scan in people with Cognitive Impairment, run by Mayo Clinic at 2 sites in United States.
Trial summary
The researchers are trying to gather information and learn more about imaging tests in racially different people who are cognitively normal or have dementia. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Tau PET scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Nov 2018to May 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female African Americans 30 years of age or older
- Subjects who have completed or are scheduled to undergo the neurological evaluation procedures described below.
Who cannot join
- Subjects unable to lie down without moving for 20 minutes.
- Women who are pregnant or cannot stop breast feeding for 24 hours.
- Claustrophobic patients unable to tolerate the scans.
- Subjects with a prolonged QT interval (as demonstrated by ECG test) cannot participate in the Tau-PET scans.
- Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc, since the quantitative PET data analysis is based on anatomic criteria that are established uniquely for each subject by registration to his/her MRI.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Mayo Clinic Minnesota
Rochester, Minnesota, 55905
About this study
The researchers are trying to gather information and learn more about imaging tests in racially different people who are cognitively normal or have dementia.
- Conditions
- Cognitive Impairment
- Being tested
- Tau PET scan
- Keywords
- African Americans, neurological exam, Dementia, Alzheimer's Disease
- Medical subject headings
- Cognitive Dysfunction, Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tau PET scanCombination product
Patient will receive a dose of flutaucipir and be scanned appropriately
| Study group | Role | What they receive |
|---|---|---|
| Normal control | Experimental | Cognitively normal volunteers Receives: Combination Product: Tau PET scan |
| Mild Cogntive impairment | Experimental | Person with cognitive impairment that meet Peterson Criteria Receives: Combination Product: Tau PET scan |
| Demented | Experimental | Patient's that meet dementia criteria Receives: Combination Product: Tau PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tau positive scans
Percentage of each of the three groups with tau positive scans
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start26 Nov 2018
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Neill R. Graff-Radford, M.D., Mayo Clinic
- Investigators
- Neill R Graff-Radford, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618186
- Sponsor's protocol ID
- 17-008710
- Other IDs
- 5P50AG016574-20
- Status last verified
- Jun 2026
- First submitted
- 2 Aug 2018
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Study
- ClinicalTrials.gov ID
- NCT03618186
- Acronym / sponsor ID
- 17-008710
- Conditions
- Cognitive Impairment
- Keywords
- African Americans, neurological exam, Dementia, Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 7 Aug 2018 (actual)
- 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.
The researchers are trying to gather information and learn more about imaging tests in racially different people who are cognitively normal or have dementia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal control | Experimental | Combination Product: Tau PET scanCognitively normal volunteers |
| Mild Cogntive impairment | Experimental | Combination Product: Tau PET scanPerson with cognitive impairment that meet Peterson Criteria |
| Demented | Experimental | Combination Product: Tau PET scanPatient's that meet dementia criteria |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female African Americans 30 years of age or older
- Subjects who have completed or are scheduled to undergo the neurological evaluation procedures described below.
Key exclusion criteria (5 listed)
- Subjects unable to lie down without moving for 20 minutes.
- Women who are pregnant or cannot stop breast feeding for 24 hours.
- Claustrophobic patients unable to tolerate the scans.
- Subjects with a prolonged QT interval (as demonstrated by ECG test) cannot participate in the Tau-PET scans.
- Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc, since the quantitative PET data analysis is based on anatomic criteria that are established uniquely for each subject by registration to his/her MRI.
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 |
|---|---|---|
| Tau PET scanPatient will receive a dose of flutaucipir and be scanned appropriately | Combination product | Demented, Mild Cogntive impairment, Normal control |
Primary outcome
Tau positive scans
Time frame: 5 years
Percentage of each of the three groups with tau positive scans
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Cognitive Impairment
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
Active, not recruiting
Primary Care Detection of Cognitive Impairment Leveraging Health & Consumer Technologies in Underserved Communities: The MyCog Trial
Dementia, Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingObservational study
Perception of Action Opportunities for Obstacle Crossing in Parkinson's Disease
PARKINSON DISEASE (Disorder), Older Adults (65-85 Years)
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.
Neill R Graff-Radford, MD principal investigator
Mayo Clinic
2 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 Tau PET scan in people with Cognitive Impairment, run by Mayo Clinic at 2 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 2 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: enrolling by invitation, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
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?
Tau positive scans (time frame: 5 years). 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 12 Jun 2026.