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

Alzheimer Disease Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Alzheimer Disease

• NCT number: NCT03047694
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Status: Terminated
• Phase: N/A
• Start date: July 15, 2019
• Completion date: January 15, 2021