Completed

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

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What is being tested

F-18 FDG

+ C-11 PiB

Drug
Who is being recruted

Alzheimer Disease+6

+ Mental Disorders

+ Brain Diseases

From 30 to 49 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Phase 1
Interventional
Study Start: July 2012
See protocol details

Summary

Principal SponsorMayo Clinic
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2012

Actual date on which the first participant was enrolled.

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.

Official TitleNormative Values for Cognitive Testing and Alzheimer's Imaging Biomarkers in Young Adults (30-49yo)
NCT01609335
Principal SponsorMayo Clinic
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

41 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 30 to 49 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Alzheimer DiseaseMental DisordersBrain DiseasesCentral Nervous System DiseasesDementiaNervous System DiseasesNeurodegenerative DiseasesNeurocognitive DisordersTauopathies

Criteria

1 inclusion criteria required to participate
Cognitively normal males or females aged 30 to 49 years old.

4 exclusion criteria prevent from participating
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Mayo Clinic Rochester

Rochester, United StatesOpen Mayo Clinic Rochester in Google Maps
CompletedOne Study Center