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: Terminated
• Conditions: Alzheimer Disease
• Intervention / Treatment: Other: tablet therapy; Other: usual care

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: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Hôpital Pitié-Salpêtrière
  • Paris, France, 75651
    • APHP - Pitié-Salpêtrière Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

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.	Other: tablet therapy; stimulation of the lexico semantic system on a tactile tablet therapy for 3 months; Other Names: Experimental Arm
Active Comparator: Control group; Patients will continue their usual care (1 or more sessions of weekly speech therapy)	Other: usual care; speech therapy; Other Names: speech therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Actual): January 15, 2021
• Study Completion (Actual): January 15, 2021

Study Registration Dates

• First Submitted: December 23, 2016
• First Submitted That Met QC Criteria: February 6, 2017
• First Posted (Estimate): February 9, 2017

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Lexico-semantic stimulation; tactile tablet
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• 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: No
• Studies a U.S. FDA-regulated device product: No