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

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ClinicalTrials.gov Identifier: NCT02740634
Recruitment Status : Recruiting
First Posted : April 15, 2016
Last Update Posted : April 13, 2022
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Jennifer Whitwell, Mayo Clinic

Study Description
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Brief Summary:
This is a neuroimaging study designed to learn more about amyloid and tau burden in the brain of patients with Atypical Alzheimer's Disease and how burden may change over a one year period.

Condition or disease Intervention/treatment Phase
Atypical Alzheimer's Disease Logopenic Progressive Aphasia (LPA) Posterior Cortical Atrophy (PCA) Drug: F-18 AV 1451 Drug: C-11 PiB Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Molecular and Structural Imaging in Atypical Alzheimer's Disease: A Longitudinal Study
Study Start Date : May 2016
Estimated Primary Completion Date : March 2026
Estimated Study Completion Date : March 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Tau PET Scan, F-18 AV 1451
All subjects will receive two Tau PET scans during this study.
 Drug: F-18 AV 1451
Tau binding agent

Drug: C-11 PiB
Amyloid binding agent
Experimental: PiB PET Scan, C-11 PiB
All subjects will receive two PiB PET scans during this study.
 Drug: F-18 AV 1451
Tau binding agent

Drug: C-11 PiB
Amyloid binding agent


Outcome Measures
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Primary Outcome Measures :
  1. Amount of Amyloid protein in the brain of patients with Logopenic Aphasia (LPA) or Posterior Cortical Atrophy (PCA). [ Time Frame: 5 years ]
  2. Amount of Tau protein in the brain of patients with Logopenic Aphasia (LPA) or Posterior Cortical Atrophy (PCA). [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Rates of change in amyloid-PET burden over time. [ Time Frame: baseline, 1 year ]
  2. Rates of change in tau-PET burden over time. [ Time Frame: baseline, 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 Logopenic Aphasia (LPA) or Posterior Cortical Atrophy (PCA).
  • All subjects with Logopenic Aphasia (LPA) must present with early and dominant impairments in language

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02740634


Contacts
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Contact: Sarah M Boland, CCRP 507-284-3863 boland.sarah@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Sarah Boland, CCRP    507-284-3863    boland.sarah@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Jennifer Whitwell, Ph.D. Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Jennifer Whitwell, Associate Professor of Radiology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02740634    
Other Study ID Numbers: 15-008682
R01AG050603 ( U.S. NIH Grant/Contract )
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: April 13, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jennifer Whitwell, Mayo Clinic:
PCA
LPA
Additional relevant MeSH terms:
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Alzheimer Disease
Aphasia
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
 Neurocognitive Disorders
Mental Disorders
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations