- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03047694
A Lexico-semantic Program on Tactile Tablet for Patients With Alzheimer's Disease (SemantiMATT)
Contribution of a Semantic Therapy on a Tactile Tablet in the Alzheimer's Disease, Early and Late Onset
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
It is a monocentric, controlled, randomized, parallel-group, single-blind clinical trial.
For each of the two forms of Alzheimer's Disease (young or late), it compares two groups of patients: a group benefiting from a tactile tablet semantic stimulation (tablet group) and a control group All patients benefit from a clinical evaluation and a language assessment at M0, M3 and M6. The analyzes will be conducted in intention to treat.
The main criterion is the 3-month variation of the Lexis 3 subtests scores. The two groups will be compared by the Student test.
The number of subjects required is based on the following assumptions: a 10% increase over three months of the Lexis subtests scores in the tablet group and a stability of the scores in the control group. The standard deviation of the variation is assumed to be identical in both groups and equal to 13% at the most. Three scores being compared, tests will be conducted at the 1.67% threshold (Bonferroni correction) to ensure a 5% overall risk of first species. The inclusion of 36 patients in each of the two treatment groups will give 80% power to the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Paris, France, 75013
- Hopital Pitie-Salpetriere
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Paris, France, 75651
- APHP - Pitié-Salpêtrière Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
- Affiliated to the Health care system
- Native french speaker,
- Attendance of a caregiver.
For the early onset group, patients should have started the disease before 65 years of age. The randomization will be stratified according to age (<65 years or> 65 years), enabling to include 2 groups of identical size of young AD (Alzheimer Disease) and Late (Alzheimer Disease) patients, each half distributed in the tablet or control group.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tablet group
Patients will continue their usual care (1 or more sessions of weekly speech therapy) and will benefit from the therapy on tablet for 3 months.
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stimulation of the lexico semantic system on a tactile tablet therapy for 3 months
Other Names:
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Active Comparator: Control group
Patients will continue their usual care (1 or more sessions of weekly speech therapy)
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speech therapy
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
variation of performance on naming subtest of the LEXIS
Time Frame: variation from baseline at 3 month
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variation from baseline at 3 month
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variation of performance on designation subtest of the LEXIS
Time Frame: variation from baseline at 3 month
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variation from baseline at 3 month
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variation of performance on semantic matching subtest of the LEXIS
Time Frame: variation from baseline at 3 month
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variation from baseline at 3 month
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
variation of performance on DO80 lexico-semantic test
Time Frame: variation from baseline at 3 month and 6 month
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variation from baseline at 3 month and 6 month
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variation of performance on verbal fluency lexico-semantic test
Time Frame: variation from baseline at 3 month and 6 month
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variation from baseline at 3 month and 6 month
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variation of performance on verbal discrimination of BADAE
Time Frame: variation from baseline at 3 month and 6 month
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variation from baseline at 3 month and 6 month
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variation of performance on episodic memory test (RL/RI)
Time Frame: variation from baseline at 3 month and 6 month
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variation from baseline at 3 month and 6 month
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variation of performance on Mini-Mental State Examination (MMSE)
Time Frame: variation from baseline at 3 month and 6 month
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variation from baseline at 3 month and 6 month
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variation of score on depression scale (HAD)
Time Frame: variation from baseline at 3 month and 6 month
|
variation from baseline at 3 month and 6 month
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variations on care giver's questionary
Time Frame: variation from baseline at 3 month and 6 month
|
variation from baseline at 3 month and 6 month
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variation of performance on naming subtest of the LEXIS
Time Frame: variation from 3 month at 6 month
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variation from 3 month at 6 month
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variation of performance on designation subtest of the LEXIS
Time Frame: variation from 3 month at 6 month
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variation from 3 month at 6 month
|
variation of performance on semantic matching subtest of the LEXIS
Time Frame: variation from 3 month at 6 month
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variation from 3 month at 6 month
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P140707
- 2015-A01312-47 (Other Identifier: IDRCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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