NCT02198586

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
575

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 23, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

1.2 years

First QC Date

July 15, 2014

Last Update Submit

March 1, 2017

Conditions

Keywords

Alzheimer's, MRI, APOE

Outcome Measures

Primary Outcomes (1)

  • Hippocampal atrophy

    2 years

Study Arms (1)

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).

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barcelonabeta Brain Research Center

Barcelona, 08003, Spain

Location

Related Publications (2)

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2014

First Posted

July 23, 2014

Study Start

April 1, 2014

Primary Completion

July 1, 2015

Study Completion

September 1, 2015

Last Updated

March 3, 2017

Record last verified: 2017-03

Locations