Apoe Impact Study on Brain Structure and Function, in a Population 45 to 75 Years Old

March 1, 2017 updated by: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
The purpose of this study is to investigate the influence of the APOE genotype on brain morphology, function and metabolism, related to other factors such as cognitive reserve, cognition and episodic memory, in subjects at greater risk of developing AD.

Study Overview

Status

Completed

Conditions

Detailed Description

The purpose of this study is to investigate the influence of age and the APOE genotype on brain morphology and function, in 700 cognitively healthy individuals, 45 to 75 years old, recruited from an ongoing longitudinal cognition study exploring memory and executive functions (ClinicalTrials.gov ID: NCT01835717).

All subjects have been APOE genotyped and underwent a clinical and cognitive assessment. Within this study, the subjects will be submitted to an MRI scanning protocol including morphological and resting state acquisitions. An identical follow-up MRI session will be performed in 2 years' time. The analyses will be focused on detecting the effect of the APOE allelic variants on the change rate of the neuroimaging variables as well as its interaction with aging.

Study Type

Observational

Enrollment (Actual)

575

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • BarcelonaBeta Brain Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The population of this study is 45 to 75 years old at the time of inclusion in the parent study (ClinicalTrials.gov ID: NCT01835717), mostly sons and daughters of AD patients.

Description

Inclusion Criteria:

  • Participant included in the study ClinicalTrials.gov ID: NCT01835717
  • APOE genotype obtained before MRI acquisition
  • Be willing to perform an MRI and agree to a 2 years longitudinal follow up
  • Sign informed consent

Exclusion Criteria:

  • Contraindication to MRI scanning: claustrophobia, pacemaker, history of ocular cerclage, heart valves, aneurysm clips and carrying any metal prosthesis incompatible with MRI.
  • Incidental MRI findings that result in the images not being included in the study.

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
No treatment
The population of this study is 45 to 75 years old at the time of inclusion in the parent study (ClinicalTrials.gov ID: NCT01835717).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hippocampal atrophy
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Investigators

  • Principal Investigator: Juan D Gispert, PhD, Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
  • Principal Investigator: José L Molinuevo, MD, PhD, IDIBAPS, Hospital Clinic de Barcelona, Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

July 15, 2014

First Submitted That Met QC Criteria

July 21, 2014

First Posted (Estimate)

July 23, 2014

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 1, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRI/FBB 2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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