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Normative Values for Cognitive Testing and Alzheimer's Imaging Biomarkers in Young Adults

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
F-18 FDG
C-11 PiB
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alzheimer's Disease

Eligibility Criteria

30 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Cognitively normal males or females aged 30 to 49 years old.

Exclusion Criteria:

  1. Subjects unable to lie down without moving for up to 45 minutes.
  2. Women who are pregnant or cannot stop breast feeding for 24 hours.
  3. Claustrophobic patients unable to tolerate the scans (no sedation can be offered).
  4. Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc.

Sites / Locations

  • Mayo Clinic Rochester

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cognitively Normal Subjects

Arm Description

Study participation will consist of tests of memory and thinking, a MRI, and two PET scans. F-18 FDG and C-11 Pittsburgh compound B (PiB) are two drugs used in PET scans.

Outcomes

Primary Outcome Measures

Normal values for amyloid PET, FDG and Magnetic Resonance Imaging
Biomarkers of Alzheimer's disease (AD) occupy an essential place in recently formulated diagnostic criteria for AD where their role is to identify the pathophysiological processes underlying cognitive impairment or to predict time to dementia. Three of these biomarkers are brain imaging tests (amyloid PET, FDG PET, and structural MRI). In order to effectively use AD biomarkers for diagnostic and prognostic purposes, continuous values much be divided into normal and abnormal ranges. This requires that a cut point(s) be established in the continuous distribution of values for each biomarker.

Secondary Outcome Measures

Full Information

First Posted
May 23, 2012
Last Updated
August 7, 2014
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01609335
Brief Title
Normative Values for Cognitive Testing and Alzheimer's Imaging Biomarkers in Young Adults
Official Title
Normative Values for Cognitive Testing and Alzheimer's Imaging Biomarkers in Young Adults (30-49yo)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Biomarkers of Alzheimer's disease (AD) occupy an essential place in recently formulated diagnostic criteria for AD where their role is to identify the pathophysiological processes underlying cognitive impairment or to predict time to dementia. Three of these biomarkers are brain imaging tests (amyloid PET, fludeoxyglucose (FDG) PET, and structural MRI). In order to effectively use AD biomarkers for diagnostic and prognostic purposes, continuous values much be divided into normal and abnormal ranges. This requires that a cut point(s) be established in the continuous distribution of values for each biomarker. The investigators objective in this proposal is to obtain imaging biomarker data in a group of individuals who are appropriate for establishing normative values for AD biomarkers. The investigators believe the most valid approach to establishing biomarker cut points is to base them on the upper bound of the range observed in young to early-middle-age subjects in whom the presence of occult AD pathology is extremely unlikely. Based on a large volume of community-based autopsy data, that upper age limit would be about 50 years old. The lower age bound for a group of subjects used to establish normative AD biomarker values would have to be based on considerations of brain maturation, which may continue into the middle- to late-20s. Thus, taking the above into consideration, the ideal age range for establishing normative AD imaging biomarker data (amyloid PET, FDG PET, and structural MRI) may be ages 30-49 years old.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitively Normal Subjects
Arm Type
Other
Arm Description
Study participation will consist of tests of memory and thinking, a MRI, and two PET scans. F-18 FDG and C-11 Pittsburgh compound B (PiB) are two drugs used in PET scans.
Intervention Type
Drug
Intervention Name(s)
F-18 FDG
Intervention Description
One time intravenous administration of 17 millicurie (mCi) +/- 10%
Intervention Type
Drug
Intervention Name(s)
C-11 PiB
Intervention Description
One time intravenous administration of 10-20 mCi
Primary Outcome Measure Information:
Title
Normal values for amyloid PET, FDG and Magnetic Resonance Imaging
Description
Biomarkers of Alzheimer's disease (AD) occupy an essential place in recently formulated diagnostic criteria for AD where their role is to identify the pathophysiological processes underlying cognitive impairment or to predict time to dementia. Three of these biomarkers are brain imaging tests (amyloid PET, FDG PET, and structural MRI). In order to effectively use AD biomarkers for diagnostic and prognostic purposes, continuous values much be divided into normal and abnormal ranges. This requires that a cut point(s) be established in the continuous distribution of values for each biomarker.
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Cognitively normal males or females aged 30 to 49 years old. Exclusion Criteria: Subjects unable to lie down without moving for up to 45 minutes. Women who are pregnant or cannot stop breast feeding for 24 hours. Claustrophobic patients unable to tolerate the scans (no sedation can be offered). Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josie Williams, BS
Organizational Affiliation
Mayo Clinic
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Normative Values for Cognitive Testing and Alzheimer's Imaging Biomarkers in Young Adults

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