Amyloïd Load in Elderly Population: Effect of Cognitive Reserve (NCT02196116) | Clinical Trial Compass
UnknownNot Applicable
Amyloïd Load in Elderly Population: Effect of Cognitive Reserve
France120 participantsStarted 2014-07
Plain-language summary
This research aim to explore relationships between the presence of amyloid burden and cognitive performance, and its modulation by educational level. For this purpose we will combine Positron emission tomography (PET) imaging and neuropsychological assessment acquired on 3 groups of subjects, from two population-based cohorts "3C" and "AMIMage" The first group includes cognitively intact participants who will serve as controls, the second group, subjects with mild cognitive impairments without memory complaint and the third, subjects with both mild cognitive impairments and memory complaint.
Who can participate
Age range
65 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:
Participation in the AMI or 3C cohorts Group 1- Controls
* MMSE \> 24 or \> 26 for low and high levels of education, respectively.
* Without memory impairment (for episodic memory) on the Free and Cued Selective Reminding Test RL/RI-16 items (FCSRT), free recall \> 22 and total recall \>42, according to the thresholds for population-based studies
* Without memory complaint
* Without dementia Group 2- Cognitively-impaired subjects without dementia and without memory complaints
* Mini Mental State Evaluation (MMSE) \< 24 or \< 26 for low and high levels of education, respectively
* With memory impairments according to the RL/RI-16 test (free recall≤22 and/or total recall ≤42), according to the thresholds for population-based studies defined by Auriacombe et al., 2010.
* Without memory complaint
* Without dementia Group 3- Cognitively-impaired subjects without dementia and with memory complaints
* MMSE \< 24 or \< 26 for low and high levels of education, respectively
* With memory impairments according to the RL/RI-16 test (same thresholds as above)
* With memory complaint
* Without dementia
Exclusion Criteria:
* Being left handed
* Presence of dementia (based on the clinical diagnosis)
* Presence of stroke
* Presence of Parkinson's disease
* Presence of a counter-indication for MRI
* Presence of a counter-indication for PET Scan with \[18F\]-Flutemetamol
* Presence of any health problem preventing travel to the imaging service of the University Hospital
…
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.