A Lexico-semantic Program on Tactile Tablet for Patients With Alzheimer's Disease (NCT03047694) | Clinical Trial Compass
TerminatedNot Applicable
A Lexico-semantic Program on Tactile Tablet for Patients With Alzheimer's Disease
Stopped: Lack of inclusion
France1 participantsStarted 2019-07-15
Plain-language summary
Lexical semantic disorders are described in Alzheimer's disease, and their incidence in everyday life is important to the extent that these disorders affect expression and comprehension.
Providing a tactile tablet stimulation, independent and complementary to speech therapy, could help to maintain certain abilities and reinforce the feeling of autonomy of the patients.
Who can participate
Age range
18 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
. Major Patient
. Patient with a diagnosis of Alzheimer's disease according to DSM-IV and NINCDS-ADRDA criteria.
. Patient at a moderate stage of the disease: Score at CDR (Clinical Dementia Rating Scale) between 0.5 inclusive and 2 inclusive and MMS score greater than or equal to 10 and lower strictly at 27
. Lexical-semantic disorder
. Treatment with pro-cognitive drugs at stable doses for at least 3 months,
. Speech therapy in progress (2 or 3 sessions per week)
. Patient with free and informed consent
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
variation of performance on naming subtest of the LEXIS
Timeframe: variation from baseline at 3 month
2
variation of performance on designation subtest of the LEXIS
Timeframe: variation from baseline at 3 month
3
variation of performance on semantic matching subtest of the LEXIS
. Other known neurological disease or general illness or major psychic problems that may interfere with cognitive functioning,
. Patient under guardianship or curatorship
. Confusion,
. Cerebral MRI (or scanner for contraindication to MRI), obtained in the context of routine care compatible with a pathological process other than that related to Alzheimer's disease. A discrete or moderate leukoaraiosis (stages 1 and 2 of Fazekas) will not be considered as a criterion of non-inclusion.
. Uncorrected hearing or visual impairment
. Inclusion in another intervention protocol.
. Participation in an additional stimulation workshop