Alzheimer DiseaseLOOPNCT03638323
Age-related Hearing Loss and Lexical Disorders
An observational study of Alzheimer Disease and Presbycusis, run by Groupe Hospitalier de la Rochelle Ré Aunis at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Disease, Presbycusis, Lexical Syntactic Disorder
- What is being tested?
- Speech therapy
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 27 Aug 2018to 31 Jan 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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)
Who may be able to join
- > 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of the Links Between Presbyacusis and Lexical Disorders in Patients With Alzheimer's Disease or Related Disease
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.
- Conditions
- Alzheimer Disease, Presbycusis, Lexical Syntactic Disorder
- Being tested
- Speech therapy
- Medical subject headings
- Alzheimer Disease, Presbycusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech therapyOther
During a 1-hour speech-language consultation, a lack of word evaluation will be conducted and patient will answer a Hearing Difficulty Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| LOOP group | Speech therapy consultation for patients with Alzheimer's disease Receives: Other: Speech therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at inclusion
Secondary outcomes (8)
Association Between Age and Lack of Word
Age of patients and score at the lack of word questionnaire (BIMM) 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) and of verbs (28 items). The results are presented in a report including scores, description of qualitative errors, and results per item. An score less than 40 indicates lack of word.
Measured: at inclusion
Association Between Gender and Lack of Word
Male or female and score at the lack of word questionnaire (BIMM) 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) and of verbs (28 items). The results are presented in a report including scores, description of qualitative errors, and results per item. An score less than 40 indicates lack of word.
Measured: at inclusion
Association Between Study Level and Lack of Word
Primary (certificate study), secondary and tertiary study (baccalaureat and more) level and score at the lack of word questionnaire (BIMM) 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) and of verbs (28 items). The results are presented in a report including scores, description of qualitative errors, and results per item. An score less than 40 indicates lack of word.
Measured: at inclusion
Association Between Accommodation Type and Lack of Word
Patient living at home or in an institution and score at the lack of word questionnaire (BIMM) 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) and of verbs (28 items). The results are presented in a report including scores, description of qualitative errors, and results per item. An score less than 40 indicates lack of word.
Measured: at inclusion
Association Between Laterality and Lack of Word
Right or left handed patients and score at the lack of word questionnaire (BIMM) 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) and of verbs (28 items). The results are presented in a report including scores, description of qualitative errors, and results per item. An score less than 40 indicates lack of word.
Measured: at inclusion
Association Between Main Diagnosis and Lack of Word
Alzheimer's disease or related disease and score at the lack of word questionnaire (BIMM) 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) and of verbs (28 items). The results are presented in a report including scores, description of qualitative errors, and results per item. An score less than 40 indicates lack of word.
Measured: at inclusion
Association Between Hearing Aid and Lack of Word
Patients with or without hearing aid and score at the lack of word questionnaire (BIMM) 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) and of verbs (28 items). The results are presented in a report including scores, description of qualitative errors, and results per item. An score less than 40 indicates lack of word.
Measured: at inclusion
Association Between Speech Therapy and Lack of Word
Patients with or without ongoing speech therapy and score at the lack of word questionnaire (BIMM) 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) and of verbs (28 items). The results are presented in a report including scores, description of qualitative errors, and results per item. An score less than 40 indicates lack of word.
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start27 Aug 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré Aunis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Laure Vignaud, Ph.D., Study director, Groupe Hospitalier de la Rochelle Ré Aunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638323
- Sponsor's protocol ID
- 2018/P08/256
- Acronym
- LOOP
- Status last verified
- Mar 2026
- First submitted
- 14 Aug 2018
- Last updated
- 19 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Links Between Presbyacusis and Lexical Disorders in Patients With Alzheimer's Disease or Related Disease
- ClinicalTrials.gov ID
- NCT03638323
- Acronym / sponsor ID
- LOOP / 2018/P08/256
- Conditions
- Alzheimer Disease, Presbycusis, Lexical Syntactic Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré AunisUniversity, hospital or other
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 20 Aug 2018 (actual)
- Results
- Posted 11 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LOOP group | – | Other: Speech therapySpeech therapy consultation for patients with Alzheimer's disease |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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)
Key inclusion criteria (6 listed)
- > 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speech therapyDuring a 1-hour speech-language consultation, a lack of word evaluation will be conducted and patient will answer a Hearing Difficulty Questionnaire | Other | LOOP group |
Primary outcome
Link Between Lack of Word and Presbycusis
Time frame: at inclusion
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.
8 secondary outcomes
Association Between Age and Lack of Word
Time frame: at inclusion
Association Between Gender and Lack of Word
Time frame: at inclusion
Association Between Study Level and Lack of Word
Time frame: at inclusion
Association Between Accommodation Type and Lack of Word
Time frame: at inclusion
Association Between Laterality and Lack of Word
Time frame: at inclusion
Association Between Main Diagnosis and Lack of Word
Time frame: at inclusion
Association Between Hearing Aid and Lack of Word
Time frame: at inclusion
Association Between Speech Therapy and Lack of Word
Time frame: at inclusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationCamille 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
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Laure Vignaud, Ph.D. study director
Groupe Hospitalier de la Rochelle Ré Aunis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Presbycusis, run by Groupe Hospitalier de la Rochelle Ré Aunis at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Link Between Lack of Word and Presbycusis (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03638323, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.