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

Primary Purpose

Atypical Alzheimer's Disease, Logopenic Progressive Aphasia (LPA), Posterior Cortical Atrophy (PCA)

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
F-18 AV 1451
C-11 PiB
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atypical Alzheimer's Disease focused on measuring PCA, LPA

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Mayo ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Tau PET Scan, F-18 AV 1451

PiB PET Scan, C-11 PiB

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rates of change in amyloid-PET burden over time.
Rates of change in tau-PET burden over time.

Full Information

First Posted
April 7, 2016
Last Updated
April 10, 2023
Sponsor
Mayo Clinic
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT02740634
Brief Title
Molecular and Structural Imaging in Atypical Alzheimer's Disease: A Longitudinal Study
Official Title
Molecular and Structural Imaging in Atypical Alzheimer's Disease: A Longitudinal Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2016 (undefined)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atypical Alzheimer's Disease, Logopenic Progressive Aphasia (LPA), Posterior Cortical Atrophy (PCA)
Keywords
PCA, LPA

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tau PET Scan, F-18 AV 1451
Arm Type
Experimental
Arm Description
All subjects will receive two Tau PET scans during this study.
Arm Title
PiB PET Scan, C-11 PiB
Arm Type
Experimental
Arm Description
All subjects will receive two PiB PET scans during this study.
Intervention Type
Drug
Intervention Name(s)
F-18 AV 1451
Intervention Description
Tau binding agent
Intervention Type
Drug
Intervention Name(s)
C-11 PiB
Intervention Description
Amyloid binding agent
Primary Outcome Measure Information:
Title
Amount of Amyloid protein in the brain of patients with Logopenic Aphasia (LPA) or Posterior Cortical Atrophy (PCA).
Time Frame
5 years
Title
Amount of Tau protein in the brain of patients with Logopenic Aphasia (LPA) or Posterior Cortical Atrophy (PCA).
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Rates of change in amyloid-PET burden over time.
Time Frame
baseline, 1 year
Title
Rates of change in tau-PET burden over time.
Time Frame
baseline, 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah M Boland, CCRP
Phone
507-284-3863
Email
boland.sarah@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Whitwell, Ph.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Boland, CCRP
Phone
507-284-3863
Email
boland.sarah@mayo.edu

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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