Molecular and Structural Imaging in Alzheimer's Disease: A Longitudinal Study

NCT ID: NCT02740634

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atypical Alzheimer's Disease Logopenic Progressive Aphasia (LPA) Posterior Cortical Atrophy (PCA) Alzheimer Disease Alzheimer Disease, Early Onset Amnestic Disorder Amnestic Symptoms Amnestic Mild Cognitive Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Tau PET Scan, F-18 AV 1451

All subjects will receive two Tau PET scans during this study.

Group Type EXPERIMENTAL

F-18 AV 1451

Intervention Type DRUG

Tau binding agent

C-11 PiB

Intervention Type DRUG

Amyloid binding agent

PiB PET Scan, C-11 PiB

All subjects will receive two PiB PET scans during this study.

Group Type EXPERIMENTAL

F-18 AV 1451

Intervention Type DRUG

Tau binding agent

C-11 PiB

Intervention Type DRUG

Amyloid binding agent

Interventions

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F-18 AV 1451

Tau binding agent

Intervention Type DRUG

C-11 PiB

Amyloid binding agent

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Whitwell

Associate Professor of Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer Whitwell, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sarah M Boland, CCRP

Role: CONTACT

507-284-3863

Facility Contacts

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Sarah Boland, CCRP

Role: primary

507-284-3863

Related Links

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Other Identifiers

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R01AG050603

Identifier Type: NIH

Identifier Source: secondary_id

View Link

15-008682

Identifier Type: -

Identifier Source: org_study_id

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