Brain Characterization of Amyloid Protein and Glucose Metabolism of ALFA Project Participants (NCT02685969) | Clinical Trial Compass
RecruitingNot Applicable
Brain Characterization of Amyloid Protein and Glucose Metabolism of ALFA Project Participants
Spain570 participantsStarted 2017-03-01
Plain-language summary
Study to understand factors related with the preclinical stages of Alzheimer's Disease and investigate markers that predict its progression.
Cross-sectional and single arm study performed on a subgroup of individuals recruited in the ALFA project.
Study without therapeutic interest for the research participants (440 participants of the ALFA project who have been selected for being cognitively healthy and in their vast majority are direct descendants of patients diagnosed with Alzheimer's Disease).
Each study candidate will be selected from the ALFA project (STUDY 45-65 FPM/2012) according to their clinical characteristics, their compliance to selection criteria and their desire to participate in this study.
After signing this study's specific informed consent form, the neuropsychological screening and the brain MRI acquisition will be performed. Once all inclusion criteria are checked, the PET scans with 18F-Flutemetamol and 18F-FDG will be performed
Who can participate
Age range
45 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* To sign the study informed consent form approved by the corresponding authorities.
* Men and women enrolled in the ALFA project (STUDY 45-65 FPM/2012).
* Participants with a cerebral MRI (magnetic resonance imaging) not suggestive of radiological incidental findings constituting an exclusion criterion.
* Cognition within psychometrically normal ranges: MMSE (Mini Mental State Examination ≥26 and Semantic Fluency (animals) ≥12.
* Score of 0 in the CDR scale (Clinical Dementia Rating).
* Good knowledge of the language and being literate.
* Female participants should be post-menopausal or present a negative pregnancy test at the moment of PET acquisition.
Exclusion Criteria:
* Present cognitive impairment.
* Presence of clinically relevant psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV-TR) criteria: major depressive disorder, generalized anxiety disorder, schizophrenia or bipolar disorder.
* Individuals with visual and/or hearing impairment.
* History of encephalitis, ictus or seizures excluding feverish convulsions during childhood.
* Severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumor (metastasis/brain cancer) as verified by magnetic resonance imaging (MRI).
* Any contraindication to MRI acquisition, (i.e., metal implants) or phobia to performing the scan as determined by the onsite physician.
* Previous participation in a clinical study involving an investigational…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prevalence of a positive 18F-Flutemetamol scan
Timeframe: Baseline
Trial details
NCT IDNCT02685969
SponsorBarcelonabeta Brain Research Center, Pasqual Maragall Foundation