A Lexico-semantic Program on Tactile Tablet for Patients With Alzheimer's Disease (SemantiMATT)

Assistance Publique - Hôpitaux de Paris

Status: Terminated

Conditions: Alzheimer Disease

Treatments: Other: tablet therapy; Other: usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT03047694

2015-A01312-47 (Other Identifier)

P140707

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Major Patient
2. Patient with a diagnosis of Alzheimer's disease according to DSM-IV and NINCDS-ADRDA criteria.
3. 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
4. Lexical-semantic disorder
5. Treatment with pro-cognitive drugs at stable doses for at least 3 months,
6. Speech therapy in progress (2 or 3 sessions per week)
7. Patient with free and informed consent
8. Affiliated to the Health care system
9. Native french speaker,
10. 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

1. Other known neurological disease or general illness or major psychic problems that may interfere with cognitive functioning,
2. Patient under guardianship or curatorship
3. Confusion,
4. 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.
5. Uncorrected hearing or visual impairment
6. Inclusion in another intervention protocol.
7. Participation in an additional stimulation workshop

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1 participants in 2 patient groups

Tablet group

Experimental group

Description:

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.

Treatment:

Other: tablet therapy

Control group

Active Comparator group

Description:

Patients will continue their usual care (1 or more sessions of weekly speech therapy)

Treatment:

Other: usual care