Atypical Alzheimer's DiseaseNCT02740634
Molecular and Structural Imaging in Alzheimer's Disease: A Longitudinal Study
A study testing F-18 AV 1451 and C-11 PiB in people with Atypical Alzheimer's Disease and Logopenic Progressive Aphasia (LPA), run by Mayo Clinic at 1 site in United States.
Trial summary
This is a neuroimaging study designed to learn more about amyloid and tau burden in the brain of patients with typical and atypical Alzheimer's Disease and how burden may change over a one year period. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Atypical Alzheimer's Disease, Logopenic Progressive Aphasia (LPA), Posterior Cortical Atrophy (PCA)
- What is being tested?
- F-18 AV 1451 and C-11 PiB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Mar 2027
- Phase
- Interventional
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over the age of 21
- Must have an informant who will be able to provide independent evaluation of functioning
- English is primary language
- All subjects must have insidious onset, report progression of their symptoms, and meet current clinical diagnostic criteria for typical amnestic AD or an atypical AD syndrome such as Logopenic Aphasia (LPA) or Posterior Cortical Atrophy (PCA).
- All subjects with Logopenic Aphasia (LPA) must present with early and dominant impairments in language
- All subjects with typical amnestic AD must have relative preservation of episodic memory compared to impairment in the non-episodic memory domain
Who cannot join
- If you have had a stroke or tumor that could explain your symptoms
- Subjects that present with early episodic memory impairment or meet clinical criteria for mild cognitive impairment will not be recruited into the study
- Subjects that meet specific criteria for another neurodegenerative disorder, including behavioral variant frontotemporal dementia, semantic dementia, primary progressive apraxia of speech, probable corticobasal syndrome, or progressive supranuclear palsy, will be excluded
- Subjects will be excluded if they have poor vision (20/400)
- Women that are pregnant or post-partum and breast-feeding will be excluded
- Subjects will be excluded from the study if they are unable to undergo the tau-PET scan due to a prolonged QT interval on ECG, or if they have any of the following genetic conditions which can increase the chance of cancer: Cowden disease, Lynch syndrome, hypogammaglobulinemia, Wiskott-Aldrich syndrome, and Down's syndrome
- Subjects will also be excluded if MRI is contraindicated (metal in head, cardiac pace maker, e.t.c.), if there is severe claustrophobia, if there are conditions that may confound brain imaging studies (e.g. structural abnormalities, including subdural hematoma or intracranial neoplasm), or if they are medically unstable or are on medications that might affect brain structure or metabolism,(e.g. chemotherapy)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Sarah Boland, CCRP, 507-284-3863, boland.sarah@mayo.edu
About this study
This is a neuroimaging study designed to learn more about amyloid and tau burden in the brain of patients with typical and atypical Alzheimer's Disease and how burden may change over a one year period.
- Conditions
- Atypical Alzheimer's Disease, Logopenic Progressive Aphasia (LPA), Posterior Cortical Atrophy (PCA), Alzheimer Disease, Alzheimer Disease, Early Onset, Amnestic Disorder
- Being tested
- F-18 AV 1451, C-11 PiB
- Keywords
- PCA, LPA, AD, Amnestic AD
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-18 AV 1451Drug
Tau binding agent
C-11 PiBDrug
Amyloid binding agent
| Study group | Role | What they receive |
|---|---|---|
| Tau PET Scan, F-18 AV 1451 | Experimental | All subjects will receive two Tau PET scans during this study. Receives: Drug: F-18 AV 1451; Drug: C-11 PiB |
| PiB PET Scan, C-11 PiB | Experimental | All subjects will receive two PiB PET scans during this study. Receives: Drug: F-18 AV 1451; Drug: C-11 PiB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Amyloid protein in the brain of patients with Logopenic Aphasia (LPA) or Posterior Cortical Atrophy (PCA).
Measured: 5 years
Amount of Tau protein in the brain of patients with Logopenic Aphasia (LPA) or Posterior Cortical Atrophy (PCA).
Measured: 5 years
Secondary outcomes (2)
Rates of change in amyloid-PET burden over time.
Measured: baseline, 1 year
Rates of change in tau-PET burden over time.
Measured: baseline, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atypical Alzheimer's DiseaseStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 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, Jennifer Whitwell, Mayo Clinic
- Investigators
- Jennifer Whitwell, Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740634
- Sponsor's protocol ID
- 15-008682
- Other IDs
- R01AG050603
- Status last verified
- Jul 2026
- First submitted
- 7 Apr 2016
- Last updated
- 17 Jul 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 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular and Structural Imaging in Alzheimer's Disease: A Longitudinal Study
- ClinicalTrials.gov ID
- NCT02740634
- Acronym / sponsor ID
- 15-008682
- Conditions
- Atypical Alzheimer's Disease, Logopenic Progressive Aphasia (LPA), Posterior Cortical Atrophy (PCA), Alzheimer Disease, Alzheimer Disease, Early Onset, Amnestic Disorder
- Keywords
- PCA, LPA, AD, Amnestic AD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- May 2016
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 15 Apr 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.
This is a neuroimaging study designed to learn more about amyloid and tau burden in the brain of patients with typical and atypical Alzheimer's Disease and how burden may change over a one year period.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tau PET Scan, F-18 AV 1451 | Experimental | Drug: F-18 AV 1451, Drug: C-11 PiBAll subjects will receive two Tau PET scans during this study. |
| PiB PET Scan, C-11 PiB | Experimental | Drug: F-18 AV 1451, Drug: C-11 PiBAll subjects will receive two PiB PET scans during this study. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Over the age of 21
- Must have an informant who will be able to provide independent evaluation of functioning
- English is primary language
- All subjects must have insidious onset, report progression of their symptoms, and meet current clinical diagnostic criteria for typical amnestic AD or an atypical AD syndrome such as Logopenic Aphasia (LPA) or Posterior Cortical Atrophy (PCA).
- All subjects with Logopenic Aphasia (LPA) must present with early and dominant impairments in language
Key exclusion criteria (7 listed)
- If you have had a stroke or tumor that could explain your symptoms
- Subjects that present with early episodic memory impairment or meet clinical criteria for mild cognitive impairment will not be recruited into the study
- Subjects that meet specific criteria for another neurodegenerative disorder, including behavioral variant frontotemporal dementia, semantic dementia, primary progressive apraxia of speech, probable corticobasal syndrome, or progressive supranuclear palsy, will be excluded
- Subjects will be excluded if they have poor vision (20/400)
- Women that are pregnant or post-partum and breast-feeding will be excluded
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 |
|---|---|---|
| F-18 AV 1451Tau binding agent | Drug | PiB PET Scan, C-11 PiB, Tau PET Scan, F-18 AV 1451 |
| C-11 PiBAmyloid binding agent | Drug | PiB PET Scan, C-11 PiB, Tau PET Scan, F-18 AV 1451 |
Primary outcome
Amount of Amyloid protein in the brain of patients with Logopenic Aphasia (LPA) or Posterior Cortical Atrophy (PCA).
Time frame: 5 years
Amount of Tau protein in the brain of patients with Logopenic Aphasia (LPA) or Posterior Cortical Atrophy (PCA).
Time frame: 5 years
2 secondary outcomes
Rates of change in amyloid-PET burden over time.
Time frame: baseline, 1 year
Rates of change in tau-PET burden over time.
Time frame: baseline, 1 year
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 17 Jul 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jennifer Whitwell, Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing F-18 AV 1451 and C-11 PiB in people with Atypical Alzheimer's Disease and Logopenic Progressive Aphasia (LPA), run by Mayo Clinic at 1 site 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Contact Sarah M Boland, CCRP (507-284-3863, boland.sarah@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of Amyloid protein in the brain of patients with Logopenic Aphasia (LPA) or Posterior Cortical Atrophy (PCA). (time frame: 5 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?
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 17 Jul 2026.