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NCT01609335 · ClinicalTrials.gov registry record · Phase 1
Normative Values for Cognitive Testing and Alzheimer's Imaging Biomarkers in Young Adults
A Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
NCT01609335: Completed Phase 1 study, sponsored by Mayo Clinic.
NCT01609335 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 41 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01609335, a Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
Study 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.
Interventions
- DRUG C-11 PiB
- DRUG F-18 FDG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2012-07 |
| Est. Completion | 2013-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01609335
The ClinicalTrials.gov registry entry for NCT01609335 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which C-11 PiB is the first listed.
NCT01609335 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01609335 about?
NCT01609335 is a clinical study titled "Normative Values for Cognitive Testing and Alzheimer's Imaging Biomarkers in Young Adults". 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 (amylo...
What is the current status of trial NCT01609335?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2012-07. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01609335?
The interventions under investigation include: C-11 PiB (DRUG), F-18 FDG (DRUG).
Who is sponsoring clinical trial NCT01609335?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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