Alzheimer's DiseaseNCT02198586
Apoe Impact Study on Brain Structure and Function, in a Population 45 to 75 Years Old
An observational study of Alzheimer's Disease, run by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- How many people
- 575 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2014to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's, MRI, APOE
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Hippocampal atrophy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 575 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan D Gispert, PhD, Principal investigator, Barcelonabeta Brain Research Center, Pasqual Maragall FoundationJosé L Molinuevo, MD, PhD, Principal investigator, IDIBAPS, Hospital Clinic de Barcelona, Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198586
- Sponsor's protocol ID
- MRI/FBB 2014
- Status last verified
- Mar 2017
- First submitted
- 15 Jul 2014
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32791423Brugulat-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.
PubMed 28341686
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apoe Impact Study on Brain Structure and Function, in a Population 45 to 75 Years Old
- ClinicalTrials.gov ID
- NCT02198586
- Acronym / sponsor ID
- MRI/FBB 2014
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's, MRI, APOE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 575 participants (actual)
- Lead sponsor
- Barcelonabeta Brain Research Center, Pasqual Maragall FoundationUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 23 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hippocampal atrophy
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Derived from this study: PubMed 32791423Ingala 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.
- Derived from this study: PubMed 28341686Brugulat-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.
- Main home pageLink provided by the sponsor.
Related trials for Alzheimer's Disease
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
Active, not recruiting
The PorchLight Project
Memory Loss, Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Active, not recruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease
Alzheimer Disease, Early Onset
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan D Gispert, PhD principal investigator
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
José L Molinuevo, MD, PhD principal investigator
IDIBAPS, Hospital Clinic de Barcelona, Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease, run by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hippocampal atrophy (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02198586, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.