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

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ClinicalTrials.gov Identifier: NCT03047694
Recruitment Status : Not yet recruiting
First Posted : February 9, 2017
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Alzheimer Disease Other: tablet therapy Other: usual care Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Contribution of a Semantic Therapy on a Tactile Tablet in the Alzheimer's Disease, Early and Late Onset
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : October 2020


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 Name: 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 Name: speech therapy




Primary Outcome Measures :
  1. variation of performance on naming subtest of the LEXIS [ Time Frame: variation from baseline at 3 month ]
  2. variation of performance on designation subtest of the LEXIS [ Time Frame: variation from baseline at 3 month ]
  3. variation of performance on semantic matching subtest of the LEXIS [ Time Frame: variation from baseline at 3 month ]

Secondary Outcome Measures :
  1. variation of performance on DO80 lexico-semantic test [ Time Frame: variation from baseline at 3 month and 6 month ]
  2. variation of performance on verbal fluency lexico-semantic test [ Time Frame: variation from baseline at 3 month and 6 month ]
  3. variation of performance on verbal discrimination of BADAE [ Time Frame: variation from baseline at 3 month and 6 month ]
  4. variation of performance on episodic memory test (RL/RI) [ Time Frame: variation from baseline at 3 month and 6 month ]
  5. variation of performance on Mini-Mental State Examination (MMSE) [ Time Frame: variation from baseline at 3 month and 6 month ]
  6. variation of score on depression scale (HAD) [ Time Frame: variation from baseline at 3 month and 6 month ]
  7. variations on care giver's questionary [ Time Frame: variation from baseline at 3 month and 6 month ]
  8. variation of performance on naming subtest of the LEXIS [ Time Frame: variation from 3 month at 6 month ]
  9. variation of performance on designation subtest of the LEXIS [ Time Frame: variation from 3 month at 6 month ]
  10. variation of performance on semantic matching subtest of the LEXIS [ Time Frame: variation from 3 month at 6 month ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03047694


Contacts
Contact: Agnès MICHON, MD 33(0)1 42 16 75 14 agnes.michon@aphp.fr

Locations
France
Hôpital Pitié-Salpêtriere Not yet recruiting
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Agnès MICHON, MD Assistance Publique Hoptiaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03047694     History of Changes
Other Study ID Numbers: P140707
2015-A01312-47 ( Other Identifier: IDRCB )
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Lexico-semantic stimulation
tactile tablet

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders