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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A01312-47 | Other Identifier | IDRCB |
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Lack of inclusion
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tablet group | Experimental | 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. |
|
| Control group | Active Comparator | Patients will continue their usual care (1 or more sessions of weekly speech therapy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tablet therapy | Other | stimulation of the lexico semantic system on a tactile tablet therapy for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| variation of performance on naming subtest of the LEXIS | variation from baseline at 3 month | |
| variation of performance on designation subtest of the LEXIS | variation from baseline at 3 month | |
| variation of performance on semantic matching subtest of the LEXIS | variation from baseline at 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| variation of performance on DO80 lexico-semantic test | variation from baseline at 3 month and 6 month | |
| variation of performance on verbal fluency lexico-semantic test | variation from baseline at 3 month and 6 month |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Agnès MICHON, MD | Assistance Publique Hoptiaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Pitié-Salpêtriere | Paris | 75013 | France | |||
| APHP - Pitié-Salpêtrière Hospital |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D013070 | Speech Therapy |
| ID | Term |
|---|---|
| D012049 | Rehabilitation of Speech and Language Disorders |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| usual care | Other | speech therapy |
|
|
| variation of performance on verbal discrimination of BADAE | variation from baseline at 3 month and 6 month |
| variation of performance on episodic memory test (RL/RI) | variation from baseline at 3 month and 6 month |
| variation of performance on Mini-Mental State Examination (MMSE) | variation from baseline at 3 month and 6 month |
| variation of score on depression scale (HAD) | variation from baseline at 3 month and 6 month |
| variations on care giver's questionary | variation from baseline at 3 month and 6 month |
| variation of performance on naming subtest of the LEXIS | variation from 3 month at 6 month |
| variation of performance on designation subtest of the LEXIS | variation from 3 month at 6 month |
| variation of performance on semantic matching subtest of the LEXIS | variation from 3 month at 6 month |
| Paris |
| 75651 |
| France |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D005791 | Patient Care |
| D013812 | Therapeutics |