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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02198586
• Other study ID #: MRI/FBB 2014
• Status: Completed
• Phase: N/A
• First received: July 15, 2014
• Last updated: March 1, 2017
• Start date: April 2014
• Est. completion date: September 2015

Study information

• Verified date: March 2017
• Source: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 575
• Est. completion date: September 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Locations

Country	Name	City	State
Spain	Barcelonabeta Brain Research Center	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hippocampal atrophy		2 years