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

NCT03047694 | Terminated

• 2 other identifiers: P1407072015-A01312-47
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

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.

Conditions

Alzheimer Disease

Keywords

Lexico-semantic stimulation; tactile tablet

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• 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

Study Arms (2)

Tablet group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Other: usual care

Interventions

tablet therapy OTHER

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

Also known as: Experimental Arm

Tablet group

usual care OTHER

speech therapy

Also known as: speech therapy

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Other known neurological disease or general illness or major psychic problems that may interfere with cognitive functioning,
• Patient under guardianship or curatorship
• Confusion,
• Uncorrected hearing or visual impairment
• Participation in an additional stimulation workshop

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Hôpital Pitié-Salpêtriere

Paris, 75013, France

Location

APHP - Pitié-Salpêtrière Hospital

Paris, 75651, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Agnès MICHON, MD

  Assistance Publique Hoptiaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2016
• First Posted: February 9, 2017
• Study Start: July 15, 2019
• Primary Completion: January 15, 2021
• Study Completion: January 15, 2021
• Last Updated: April 24, 2023

Record last verified: 2023-04

Locations

FR (2)