Pilot Study of the Links Between Presbyacusis and Lexical Disorders in Patients With Alzheimer's Disease or Related Disease
Conditions: Alzheimer Disease, Presbycusis, Lexical Syntactic Disorder
Sponsor: Groupe Hospitalier de la Rochelle Ré Aunis

 
N°  protocole : 2018/P08/256 
Version n° 2.0 du 08/06/2018 
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Pilot study of the links between presbyacusis and lexical disorders in 
patients with Alzheimer’s disease or related disease (LOOP) 
 
1. Justification / context 
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, we are investigating lexical disorders. 
 
2. Objectives 
2.1. Main objective 
To determine the relationship between word loss and presbycusis suspected or proven in patients with 
Alzheimer's disease or related disorders. 
 
2.2. Secondary objective 
Study variables associated with word loss in patients with Alzheimer's disease or related disorders. 
 
3. Outcome measures 
3.1. Primary outcome measure 
The lack of word score (BIMM questionnaire) according to the score at the hearing questionnaire. 
 
3.2. Secondary outcome measure 
Age, gender, socio-cultural level, accommodation, laterality, main diagnosis, hearing aid, speech 
language therapy according to lack of word score. 
 
4. Outline of the research 
Monocentric study on a series of cases. 
 
5. Eligibility criteria 
5.1. Inclusion criteria 
- > 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 
 
5.2. Exclusion criteria 
- 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 
 

 
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6. Feasibility and recruitment procedures 
Recruitment will take place in the various departments of the Centre de Soins pour Personnes Agées 
(CSPA): geriatric day hospital, long-term care units, follow-up care and rehabilitation units. 
 
7. Research procedures 
7.1. Consent 
During the inclusion visit, the doctor, neuropsychologist or speech-language pathologist informs the 
participant and answers all questions about the objective, the nature of the constraints, and the 
expected benefits of the research. It also specifies the participant's rights in a research project and 
checks the eligibility criteria. The patient gives his or her consent orally or in writing, which is 
documented in the medical file. 
 
7.2. Conducting the visit 
Study participants will benefit from an additional speech therapy consultation of approximately one 
hour. During this visit, they will pass the lack of word questionnaire (BIMM noun and verb naming 
tests) and complete the hearing questionnaire. 
 
7.3. Rules for stopping a person from participating in the research 
At any time, if desired, the patient may withdraw from the study. He will continue to receive the best 
possible medical care. 
Discontinuations from research will be patients for whom evaluations have not been completed. These 
patients will not be replaced. 
 
8. Study size 
Expected new entries are of 10 patients per month at the Centre de Soins pour Personnes Agées.  The 
recruitment potential is 50 patients over the duration of the study. 
Taking into account possible refusals to participate, patient availability and service organization, we 
plan to enroll 45 patients. 
 
9. Duration 
- Duration of the inclusion period: 5 months 
- Participation duration of each participant: 1 hour 
- Total duration of the research: 5 months 
 
10. Statistical aspects 
The parameters collected will be presented in tables with descriptive statistics for the entire study 
population and sub-populations (patients with hearing impairment and patients without hearing 
impairment).  
 
The correlation study between the overall score obtained at the lack of word questionnaire and the 
score obtained at the hearing questionnaire will be presented in a scatter plot and the Pearson 
correlation coefficient will be calculated. 
 
The study of the relationship between factors and word deficiency in patients with Alzheimer's disease 
or related disorders will be carried out by bivariate analysis and then by logistic regression. 
 
11. Monitoring of the research 
11.1. 
Access to data 
Acceptance of participation in the protocol implies that carers will make available the documents and 
individual data strictly necessary for the monitoring, quality control and audit of the research, to 
persons having access to these documents in accordance with the laws and regulations in force. 

 
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11.2. 
Source data 
All information contained in original documents, or in authenticated copies of these documents, 
relating to clinical examinations, observations or other activities conducted as part of a research study 
and necessary for the reconstitution and evaluation of the research. The documents in which the source 
data are saved are called the source documents.  
The data that will be entered directly into the case report form and that will not have any source data 
as a result are all the scores and reaction times obtained in the lack of word and hearing questionnaires. 
 
11.3. 
Data confidentiality  
In accordance with the legislative provisions in force, persons having direct access to source data will 
take all the necessary precautions to ensure the confidentiality of information relating to 
investigational medicinal products, research, participants, especially as regards their identity and the 
results obtained. These people, like the investigators, are subject to professional secrecy. 
 
During or at the end of the research, the data collected on the participants and sent to the sponsor by 
the investigators (or any other specialised contributor) will made anonymous. The data must never 
explicitly mention the names of the persons concerned or their addresses. 
 
12. Expected benefits  
If this study does show a link between presbycusis and lexical disorders in patients with Alzheimer's 
disease or related disorders, a new study will be required in a larger, multicentre population to confirm 
the results.  
Prevention and management of patients with Alzheimer's disease or related disorders could be 
improved. Indeed, systematic screening for hearing disorders could be considered as soon as 
Alzheimer's or related diseases are suspected. In addition, in these patients, speech and language 
therapy management may evolve to include two areas: management of language and memory 
disorders, and management of hearing disorders.