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

Alzheimer's Disease Clinical Trial

Official title:

Normative Values for Cognitive Testing and Alzheimer's Imaging Biomarkers in Young Adults (30-49yo)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01609335
• Other study ID #: 11-006972
• Status: Completed
• Phase: Phase 1
• First received: May 23, 2012
• Last updated: August 7, 2014
• Start date: July 2012
• Est. completion date: August 2013

Study information

• Verified date: August 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 49 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• F-18 FDG
One time intravenous administration of 17 millicurie (mCi) +/- 10%
• C-11 PiB
One time intravenous administration of 10-20 mCi

Locations

Country	Name	City	State
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 days	No