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

April 21, 2023 updated by: Assistance Publique - Hôpitaux de Paris

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Paris, France, 75013
        • Hopital Pitie-Salpetriere
      • Paris, France, 75651
        • APHP - Pitié-Salpêtrière Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
variation of performance on naming subtest of the LEXIS
Time Frame: variation from baseline at 3 month
variation from baseline at 3 month
variation of performance on designation subtest of the LEXIS
Time Frame: variation from baseline at 3 month
variation from baseline at 3 month
variation of performance on semantic matching subtest of the LEXIS
Time Frame: variation from baseline at 3 month
variation from baseline at 3 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
variation of performance on DO80 lexico-semantic test
Time Frame: variation from baseline at 3 month and 6 month
variation from baseline at 3 month and 6 month
variation of performance on verbal fluency lexico-semantic test
Time Frame: variation from baseline at 3 month and 6 month
variation from baseline at 3 month and 6 month
variation of performance on verbal discrimination of BADAE
Time Frame: variation from baseline at 3 month and 6 month
variation from baseline at 3 month and 6 month
variation of performance on episodic memory test (RL/RI)
Time Frame: variation from baseline at 3 month and 6 month
variation from baseline at 3 month and 6 month
variation of performance on Mini-Mental State Examination (MMSE)
Time Frame: variation from baseline at 3 month and 6 month
variation from baseline at 3 month and 6 month
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
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
variation of performance on naming subtest of the LEXIS
Time Frame: variation from 3 month at 6 month
variation from 3 month at 6 month
variation of performance on designation subtest of the LEXIS
Time Frame: variation from 3 month at 6 month
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
variation from 3 month at 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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