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

NCT ID: NCT02198586

Last Updated: 2017-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

575 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Alzheimer's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juan D Gispert, PhD

Role: PRINCIPAL_INVESTIGATOR

Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

José L Molinuevo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

IDIBAPS, Hospital Clinic de Barcelona, Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Locations

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Barcelonabeta Brain Research Center

Barcelona, , Spain

Site Status

Countries

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Spain

References

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Ingala S, Mazzai L, Sudre CH, Salvado G, Brugulat-Serrat A, Wottschel V, Falcon C, Operto G, Tijms B, Gispert JD, Molinuevo JL, Barkhof F; ALFA Study. The relation between APOE genotype and cerebral microbleeds in cognitively unimpaired middle- and old-aged individuals. Neurobiol Aging. 2020 Nov;95:104-114. doi: 10.1016/j.neurobiolaging.2020.06.015. Epub 2020 Jun 29.

Reference Type DERIVED
PMID: 32791423 (View on PubMed)

Brugulat-Serrat A, Rojas S, Bargallo N, Conesa G, Minguillon C, Fauria K, Gramunt N, Molinuevo JL, Gispert JD. Incidental findings on brain MRI of cognitively normal first-degree descendants of patients with Alzheimer's disease: a cross-sectional analysis from the ALFA (Alzheimer and Families) project. BMJ Open. 2017 Mar 24;7(3):e013215. doi: 10.1136/bmjopen-2016-013215.

Reference Type DERIVED
PMID: 28341686 (View on PubMed)

Related Links

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Other Identifiers

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MRI/FBB 2014

Identifier Type: -

Identifier Source: org_study_id

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