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

Primary Purpose

Alzheimer Disease

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

tablet therapy

usual care

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Lexico-semantic stimulation, tactile tablet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hôpital Pitié-Salpêtriere
APHP - Pitié-Salpêtrière Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tablet group

Control group

Arm 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.

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

Outcomes

Primary Outcome Measures

variation of performance on naming subtest of the LEXIS

variation of performance on designation subtest of the LEXIS

variation of performance on semantic matching subtest of the LEXIS

Secondary Outcome Measures

variation of performance on DO80 lexico-semantic test

variation of performance on verbal fluency lexico-semantic test

variation of performance on verbal discrimination of BADAE

variation of performance on episodic memory test (RL/RI)

variation of performance on Mini-Mental State Examination (MMSE)

variation of score on depression scale (HAD)

variations on care giver's questionary

variation of performance on naming subtest of the LEXIS

variation of performance on designation subtest of the LEXIS

variation of performance on semantic matching subtest of the LEXIS

Full Information

NCT ID

NCT03047694

First Posted

December 23, 2016

Last Updated

April 21, 2023

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT03047694

Brief Title

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

Acronym

SemantiMATT

Official Title

Contribution of a Semantic Therapy on a Tactile Tablet in the Alzheimer's Disease, Early and Late Onset

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Terminated

Why Stopped

Lack of inclusion

Study Start Date

July 15, 2019 (Actual)

Primary Completion Date

January 15, 2021 (Actual)

Study Completion Date

January 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

Keywords

Lexico-semantic stimulation, tactile tablet

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tablet group

Arm Type

Experimental

Arm 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.

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

tablet therapy

Other Intervention Name(s)

Experimental Arm

Intervention Description

stimulation of the lexico semantic system on a tactile tablet therapy for 3 months

Intervention Type

Other

Intervention Name(s)

usual care

Other Intervention Name(s)

speech therapy

Intervention Description

speech therapy

Primary Outcome Measure Information:

Title

variation of performance on naming subtest of the LEXIS

Time Frame

variation from baseline at 3 month

Title

variation of performance on designation subtest of the LEXIS

Time Frame

variation from baseline at 3 month

Title

variation of performance on semantic matching subtest of the LEXIS

Time Frame

variation from baseline at 3 month

Secondary Outcome Measure Information:

Title

variation of performance on DO80 lexico-semantic test

Time Frame