NCT03638323

Brief Summary

In France, Alzheimer's disease accounts for 70 to 80% of the causes of neurocognitive disorders, i.e. 600,000 to 800,000 patients. It is a neurodegenerative pathology that causes evolutionary cognitive dysfunction, mainly affecting memory functions. The inability to name familiar objects (lack of the word) is one of the most commonly noted symptoms at an early stage of the disease. Presbyacusis, or age-related hearing loss, is the most common sensory deficit in the elderly which is manifested socially by a progressive discomfort of verbal communication. Presbyacusis remains underdiagnosed and undertreated: 2/3 of the patients are not using hearing aid. In recent years, a link between neurocognitive disorders and hearing loss has been shown by investigating general cognition. In this study, the investigators are investigating lexical disorders.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

August 27, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
7 months until next milestone

Results Posted

Study results publicly available

September 11, 2019

Completed
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

August 14, 2018

Results QC Date

May 13, 2019

Last Update Submit

March 2, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Link Between Lack of Word and Presbycusis

    The Batterie Informatisée du Manque du Mot (BIMM) is a computerized assessment instrument for denominational disorders. It provides information on level of lexical impairment, type of error (phonological, semantic, visual perceptual) and response time. It comprises two tests: denomination of nouns (42 items, score range from 0 to 42) and of verbs (28 items, score range from 0 to 28). The results are presented in a report including scores, description of qualitative errors, and results per item. A global score of less than 40 indicates a lack of words. The score range is between 0 and 70. The hearing questionnaire consists in 14 questions about concrete situations and a direct question about what the patient thinks of his hearing. Answers are quoted 0, 2 or 4 points. An overall score greater than 14 indicates presbycusis.

    at inclusion

Secondary Outcomes (8)

  • Association Between Age and Lack of Word

    at inclusion

  • Association Between Gender and Lack of Word

    at inclusion

  • Association Between Study Level and Lack of Word

    at inclusion

  • Association Between Accommodation Type and Lack of Word

    at inclusion

  • Association Between Laterality and Lack of Word

    at inclusion

  • +3 more secondary outcomes

Study Arms (1)

LOOP group

Speech therapy consultation for patients with Alzheimer's disease

Other: Speech therapy

Interventions

During a 1-hour speech-language consultation, a lack of word evaluation will be conducted and patient will answer a Hearing Difficulty Questionnaire

LOOP group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Series of patients from the Care Center for the Elderly (geriatric day hospital, long-term care units, follow-up care units and rehabilitation)

You may qualify if:

  • \> 65 years old
  • French mother tongue
  • Good vision with or without correction
  • Alzheimer's or related disease (15 \<Mini-Mental State Examination\<25)
  • Affiliate or beneficiary of a social security
  • Informed consent

You may not qualify if:

  • Cognitive disorders related to another pathology (cerebrovascular accident, head trauma, epilepsy ...)
  • Protected patient (under guardianship) or person deprived of liberty by judicial or administrative decision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier de la Rochelle Ré Aunis

La Rochelle, France

Location

Related Publications (1)

  • Camille Roche, Aude Bournazel, Caroline Allix-Béguec, Marie-Laure Pinon-Vignaud. Étude pilote des liens entre la presbyacousie et les troubles lexicaux chez les patients atteints de maladie d'Alzheimer ou maladie apparentée. Audiology Direct. September 2020. DOI: 10.1051/audiodir/202004002

    RESULT

MeSH Terms

Conditions

Alzheimer DiseasePresbycusis

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersHearing Loss, SensorineuralHearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language DisordersRehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Results Point of Contact

Title
Marie-Laure Vignaud, neuropsychologist
Organization
Groupe Hospitalier de la Rochelle Ré Aunis

Study Officials

  • Marie-Laure Vignaud, Ph.D.

    Groupe Hospitalier de la Rochelle Ré Aunis

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2018

First Posted

August 20, 2018

Study Start

August 27, 2018

Primary Completion

January 31, 2019

Study Completion

January 31, 2019

Last Updated

March 19, 2026

Results First Posted

September 11, 2019

Record last verified: 2026-03

Locations