Text Size

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Val Lowe, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01609335
First received: May 23, 2012
Last updated: January 21, 2013
Last verified: January 2013
History of Changes
  Purpose

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.

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.


Condition Intervention
Alzheimer's Disease
 Drug: F-18 FDG
Drug: C-11 PiB

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Normative Values for Cognitive Testing and Alzheimer's Imaging Biomarkers in Young Adults (30-49yo)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Normal values for amyloid PET, FDG and MR Imaging [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    Biomarkers of Alzheimer's disease (AD) occupy an essential place in recently formulated diagnostic criteria for AD where their role is to identify the pathophsyiological 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.


Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Cognitively Normal Males and Females aged 30 to 49 years old Drug: F-18 FDG
One time intravenous administration of 17 mCI +/- 10%
Drug: C-11 PiB
One time intravenous administration of 10-20 mCi

  Eligibility

Ages Eligible for Study:   30 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609335

Locations
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
  More Information

No publications provided

Responsible Party: Val Lowe, Consultant - Diagnostic Radiology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01609335     History of Changes
Other Study ID Numbers: 11-006972
Study First Received: May 23, 2012
Last Updated: January 21, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013