Cognitive DeclineADIMANCT04342520
Anxiety Related to the Diagnosis of Alzheimer's Disease or Related Diseases
An observational study of Cognitive Decline, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Improving the diagnosis of neurocognitive disorders is a major public health challenge. This diagnosis occurs too late in the majority of cases, or is even sometimes non-existent for some despite the presence of clinical signs and symptoms. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Cognitive Decline
- What is being tested?
- Dyads Patient / caregiver
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 16 May 2022to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient / caregiver likely to participate in the study will be identified in a memory clinic as part of their regular medical course.
Who may be able to join
- Patients :
- Man or woman 55 years and over
- Patient received for the first time in Memory Consultation and not aware of his diagnosis
- Patient with a Mini-Mental State Assessment score (MMSE) ≥ 20
- Patient accompanied by a primary caregiver
- Patient able to provide consent to participate in research
Show all 9Show fewer
- Caregiver:
- The caregiver accompanies the patient and is considered as the main caregiver during the consultation
- is able to provide consent to participate in research
Who cannot join
- Patient living in a care homes
- Patient protected by law (under legal protection, guardianship or trusteeship)
- Patient with a hearing or visual impairment that does not allow to carry out assessments in Memory Consultation
- Patient opposing research
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital des Charpennes (HCL)
Lyon, 69100
Sophie DAUTRICOURT, Dr, +33472432174 ext. +33, sophie.dautricourt@chu-lyon.fr
About this study
Improving the diagnosis of neurocognitive disorders is a major public health challenge. This diagnosis occurs too late in the majority of cases, or is even sometimes non-existent for some despite the presence of clinical signs and symptoms. However, the etiological diagnosis of a TNC is crucial for the patient and his family to understand the most appropriate decisions for the future, to plan the organization of his life as long as he is able to do so, to access the clinical research, to promote dialogue between patients and their caregivers. On the contrary, a late diagnosis may be responsible for the fact that the patient and his / her family are less able to benefit from certain psychosocial interventions, services and treatments.
But the diagnostic announcement is retained. One of the negative and dreaded effects of such an announcement is the negative psychological impact. Some studies show that the diagnostic announcement would worsen the level of anxiety or depressed mood and the risk of social isolation. On the other hand, other studies show that symptoms such as anxiety, psychic distress and depression remain stable, or even decrease slightly after the announcement of the diagnosis, in patients and their relatives. However, the literature is questionable because the majority of the studies are retrospective, mono-centric, and the patient numbers are low. While the first reactions of patients may be negative after the announcement, some report resignation experiences, or form of relief, because they have finally found a clinical explanation for the symptoms encountered. While doubt or diagnostic uncertainty, as well as the feeling of not knowing the truth, seem to have a more damaging psychological impact on the patient and those around him, increasing anxiety and confusion.
Read more
The primary objective is to study if the level of anxiety 2 months after the announcement of the diagnosis of Alzheimer's disease or a related disease is not superior to the level of anxiety before the announcement with patient / caregiver.
This present study aim to explore the feasibility with 14 patients.
Read the detailed description
Improving the diagnosis of neurocognitive disorders is a major public health challenge. This diagnosis occurs too late in the majority of cases, or is even sometimes non-existent for some despite the presence of clinical signs and symptoms. However, the etiological diagnosis of a TNC is crucial for the patient and his family to understand the most appropriate decisions for the future, to plan the organization of his life as long as he is able to do so, to access the clinical research, to promote dialogue between patients and their caregivers. On the contrary, a late diagnosis may be responsible for the fact that the patient and his / her family are less able to benefit from certain psychosocial interventions, services and treatments.
But the diagnostic announcement is retained. One of the negative and dreaded effects of such an announcement is the negative psychological impact. Some studies show that the diagnostic announcement would worsen the level of anxiety or depressed mood and the risk of social isolation. On the other hand, other studies show that symptoms such as anxiety, psychic distress and depression remain stable, or even decrease slightly after the announcement of the diagnosis, in patients and their relatives. However, the literature is questionable because the majority of the studies are retrospective, mono-centric, and the patient numbers are low. While the first reactions of patients may be negative after the announcement, some report resignation experiences, or form of relief, because they have finally found a clinical explanation for the symptoms encountered. While doubt or diagnostic uncertainty, as well as the feeling of not knowing the truth, seem to have a more damaging psychological impact on the patient and those around him, increasing anxiety and confusion.
The primary objective is to study if the level of anxiety 2 months after the announcement of the diagnosis of Alzheimer's disease or a related disease is not superior to the level of anxiety before the announcement with patient / caregiver.
This present study aim to explore the feasibility with 14 patients.
- Conditions
- Cognitive Decline
- Being tested
- Dyads Patient / caregiver
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyads Patient / caregiverOther
adult patient / caregiver couples, patient are 55 years of age or older and have Alzheimer's disease or a related disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety (Y-B form) of the State Trait Anxiety Inventory (STAI) scale
The anxiety score (Y-B form) of the State Trait Anxiety Inventory (STAI) scale, assess the level of anxiety in daily life. The range of this score is from 20 to 80.
Measured: at inclusion
Anxiety (Y-B form) of the State Trait Anxiety Inventory (STAI) scale
The anxiety score (Y-B form) of the State Trait Anxiety Inventory (STAI) scale, assess the level of anxiety in daily life. The range of this score is from 20 to 80.
Measured: at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start16 May 2022
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342520
- Sponsor's protocol ID
- 2019-A02620-57
- Acronym
- ADIMA
- Status last verified
- Jan 2023
- First submitted
- 3 Apr 2020
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety Related to the Diagnosis of Alzheimer's Disease or Related Diseases
- ClinicalTrials.gov ID
- NCT04342520
- Acronym / sponsor ID
- ADIMA / 2019-A02620-57
- Conditions
- Cognitive Decline
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 13 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Improving the diagnosis of neurocognitive disorders is a major public health challenge. This diagnosis occurs too late in the majority of cases, or is even sometimes non-existent for some despite the presence of clinical signs and symptoms. However, the etiological diagnosis of a TNC is crucial for the patient and his family to understand the most appropriate decisions for the future, to plan the organization of his life as long as he is able to do so, to access the clinical research, to promote dialogue between patients and their caregivers. On the contrary, a late diagnosis may be responsible for the fact that the patient and his / her family are less able to benefit from certain psychosocial interventions, services and treatments.
But the diagnostic announcement is retained. One of the negative and dreaded effects of such an announcement is the negative psychological impact. Some studies show that the diagnostic announcement would worsen the level of anxiety or depressed mood and the risk of social isolation. On the other hand, other studies show that symptoms such as anxiety, psychic distress and depression remain stable, or even decrease slightly after the announcement of the diagnosis, in patients and their relatives. However, the literature is questionable because the majority of the studies are retrospective, mono-centric, and the patient numbers are low. While the first reactions of patients may be negative after the announcement, some report resignation experiences, or form of relief, because they have finally found a clinical explanation for the symptoms encountered. While doubt or diagnostic uncertainty, as well as the feeling of not knowing the truth, seem to have a more damaging psychological impact on the patient and those around him, increasing anxiety and confusion.
The primary objective is to study if the level of anxiety 2 months after the announcement of the diagnosis of Alzheimer's disease or a related disease is not superior to the level of anxiety before the announcement with patient / caregiver.
This present study aim to explore the feasibility with 14 patients.
Detailed description
Improving the diagnosis of neurocognitive disorders is a major public health challenge. This diagnosis occurs too late in the majority of cases, or is even sometimes non-existent for some despite the presence of clinical signs and symptoms. However, the etiological diagnosis of a TNC is crucial for the patient and his family to understand the most appropriate decisions for the future, to plan the organization of his life as long as he is able to do so, to access the clinical research, to promote dialogue between patients and their caregivers. On the contrary, a late diagnosis may be responsible for the fact that the patient and his / her family are less able to benefit from certain psychosocial interventions, services and treatments.
But the diagnostic announcement is retained. One of the negative and dreaded effects of such an announcement is the negative psychological impact. Some studies show that the diagnostic announcement would worsen the level of anxiety or depressed mood and the risk of social isolation. On the other hand, other studies show that symptoms such as anxiety, psychic distress and depression remain stable, or even decrease slightly after the announcement of the diagnosis, in patients and their relatives. However, the literature is questionable because the majority of the studies are retrospective, mono-centric, and the patient numbers are low. While the first reactions of patients may be negative after the announcement, some report resignation experiences, or form of relief, because they have finally found a clinical explanation for the symptoms encountered. While doubt or diagnostic uncertainty, as well as the feeling of not knowing the truth, seem to have a more damaging psychological impact on the patient and those around him, increasing anxiety and confusion.
The primary objective is to study if the level of anxiety 2 months after the announcement of the diagnosis of Alzheimer's disease or a related disease is not superior to the level of anxiety before the announcement with patient / caregiver.
This present study aim to explore the feasibility with 14 patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient / caregiver likely to participate in the study will be identified in a memory clinic as part of their regular medical course.
Key inclusion criteria (9 listed)
- Patients :
- Man or woman 55 years and over
- Patient received for the first time in Memory Consultation and not aware of his diagnosis
- Patient with a Mini-Mental State Assessment score (MMSE) ≥ 20
- Patient accompanied by a primary caregiver
Key exclusion criteria (4 listed)
- Patient living in a care homes
- Patient protected by law (under legal protection, guardianship or trusteeship)
- Patient with a hearing or visual impairment that does not allow to carry out assessments in Memory Consultation
- Patient opposing research
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 |
|---|---|---|
| Dyads Patient / caregiveradult patient / caregiver couples, patient are 55 years of age or older and have Alzheimer's disease or a related disease | Other | – |
Primary outcome
Anxiety (Y-B form) of the State Trait Anxiety Inventory (STAI) scale
Time frame: at inclusion
The anxiety score (Y-B form) of the State Trait Anxiety Inventory (STAI) scale, assess the level of anxiety in daily life. The range of this score is from 20 to 80.
Anxiety (Y-B form) of the State Trait Anxiety Inventory (STAI) scale
Time frame: at 2 months
The anxiety score (Y-B form) of the State Trait Anxiety Inventory (STAI) scale, assess the level of anxiety in daily life. The range of this score is from 20 to 80.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Individual participant dataSharing planned: No
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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.
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 Cognitive Decline, run by Hospices Civils de Lyon 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 9 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophie DAUTRICOURT, Dr (+334 72 43 21 74 ext. +33, sophie.dautricourt@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (Y-B form) of the State Trait Anxiety Inventory (STAI) scale (time frame: at inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2023.