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Clinical Trials/NCT02740634
NCT02740634
Active, not recruiting
Not Applicable

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

Mayo Clinic1 site in 1 country60 target enrollmentMay 1, 2016

Overview

Phase
Not Applicable
Intervention
F-18 AV 1451
Conditions
Amnestic Symptoms
Sponsor
Mayo Clinic
Enrollment
60
Locations
1
Primary Endpoint
Amount of Tau protein in the brain of patients with Logopenic Aphasia (LPA) or Posterior Cortical Atrophy (PCA).
Status
Active, not recruiting
Last Updated
23 days ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
May 1, 2016
End Date
March 1, 2027
Last Updated
23 days ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jennifer Whitwell

Associate Professor of Radiology

Mayo Clinic

Eligibility 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 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)

Arms & Interventions

Tau PET Scan, F-18 AV 1451

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

Intervention: F-18 AV 1451

Tau PET Scan, F-18 AV 1451

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

Intervention: C-11 PiB

PiB PET Scan, C-11 PiB

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

Intervention: F-18 AV 1451

PiB PET Scan, C-11 PiB

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

Intervention: C-11 PiB

Outcomes

Primary Outcomes

Amount of Tau protein in the brain of patients with Logopenic Aphasia (LPA) or Posterior Cortical Atrophy (PCA).

Time Frame: 5 years

Amount of Amyloid protein in the brain of patients with Logopenic Aphasia (LPA) or Posterior Cortical Atrophy (PCA).

Time Frame: 5 years

Secondary Outcomes

  • Rates of change in amyloid-PET burden over time.(baseline, 1 year)
  • Rates of change in tau-PET burden over time.(baseline, 1 year)

Study Sites (1)

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