Posterior Cortical AtrophyREEDUC-ACPNCT04041089
Development of the Effectiveness of Rehabilitation Tools for Neurovisual Disorders in Patients With Posterior Cortical Atrophy
A study testing Recognition of objects, Location of objects and Manipulation of objects in people with Posterior Cortical Atrophy, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Posterior cortical atrophy (PCA) is manifested by neuro-visual disorders that alter the spatial location of objects, their manipulation and/or recognition. Its etiology is most often neurodegenerative, with a major impact on the autonomy and mood of patients and their families. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Posterior Cortical Atrophy
- What is being tested?
- Recognition of objects, Location of objects and Manipulation of objects
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 2 Sep 2019to 15 Jun 2022
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >50 years old
- Male or Female
- Patients with a diagnosis of PCA according to the criteria of Tang-Wai et al (2004)
- MMS>15
- Voluntary, written and informed consent of the patient himself or its legal representative (guardian/curator), with oral consent of the patient in all cases
- Anti-Alzheimer's and psychotropic treatments stable for one month, if taken by the patient
- Affiliation to a social security system
Who cannot join
- Uncorrected visual disorders with non-degenerative etiology (AV<0.5)
- Person under the protection of justice
- Pregnant women (a pregnancy test will be performed in premenopausal women)
Trial locations and contacts
1 site in 1 country.
France1 site
Institut Claude Pompidou - Centre Mémoire de Ressources et de Recherche du CHU de Nice
Nice, Alpes-Maritime, 06100
About this study
Official title: Development and Evaluation of the Effectiveness of Rehabilitation Tools for Neurovisual Disorders in Patients With Posterior Cortical Atrophy (PCA)
Posterior cortical atrophy (PCA) is manifested by neuro-visual disorders that alter the spatial location of objects, their manipulation and/or recognition. Its etiology is most often neurodegenerative, with a major impact on the autonomy and mood of patients and their families. Few studies have focused on non-medication management of these disorders.
The present study thus has a double objective: the development of a complete tool to work on the recognition, localization and/or manipulation of objects; and the evaluation of the effectiveness of this type of management.
- Conditions
- Posterior Cortical Atrophy
- Being tested
- Recognition of objects, Location of objects, Manipulation of objects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recognition of objectsBehavioural
- Name of shapes / colors / images / objects
- Classification of shapes / colors / images / objects
Location of objectsBehavioural
- Search for frequent/rarse targets among distractors sharing one or more characteristics with the target
- Hit/catch a stationary/mobile target as quickly as possible
Manipulation of objectsBehavioural
- Storage of shapes/objects
- Use of everyday objects (pen, cutlery, etc.)
| Study group | Role | What they receive |
|---|---|---|
| Recognition of objects | Experimental | Patients will do the therapy in the following order: object location, object manipulation and object recognition Receives: Behavioral: Recognition of objects |
| Location of objects | Experimental | Patients will do the therapy in the following order: object recognition, object location, and object manipulation Receives: Behavioral: Location of objects |
| Manipulation of objects | Experimental | Patients will do the therapy in the following order: object manipulation, object recognition and object location Receives: Behavioral: Manipulation of objects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness evaluation
Effectiveness will be evaluated a score based on success rate (from 0 to 10), reaction time and eye-recording .
Measured: At week 34
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start2 Sep 2019
- Primary completion15 Jun 2021
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Cortical AtrophyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MOUTON Aurélie, Ph, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041089
- Sponsor's protocol ID
- 18-AOI-02
- Acronym
- REEDUC-ACP
- Status last verified
- Feb 2023
- First submitted
- 30 Jul 2019
- Last updated
- 22 Mar 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 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of the Effectiveness of Rehabilitation Tools for Neurovisual Disorders in Patients With Posterior Cortical Atrophy (PCA)
- ClinicalTrials.gov ID
- NCT04041089
- Acronym / sponsor ID
- REEDUC-ACP / 18-AOI-02
- Conditions
- Posterior Cortical Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 1 Aug 2019 (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.
Posterior cortical atrophy (PCA) is manifested by neuro-visual disorders that alter the spatial location of objects, their manipulation and/or recognition. Its etiology is most often neurodegenerative, with a major impact on the autonomy and mood of patients and their families. Few studies have focused on non-medication management of these disorders.
The present study thus has a double objective: the development of a complete tool to work on the recognition, localization and/or manipulation of objects; and the evaluation of the effectiveness of this type of management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Recognition of objects | Experimental | Behavioral: Recognition of objectsPatients will do the therapy in the following order: object location, object manipulation and object recognition |
| Location of objects | Experimental | Behavioral: Location of objectsPatients will do the therapy in the following order: object recognition, object location, and object manipulation |
| Manipulation of objects | Experimental | Behavioral: Manipulation of objectsPatients will do the therapy in the following order: object manipulation, object recognition and object location |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >50 years old
- Male or Female
- Patients with a diagnosis of PCA according to the criteria of Tang-Wai et al (2004)
- MMS>15
- Voluntary, written and informed consent of the patient himself or its legal representative (guardian/curator), with oral consent of the patient in all cases
Key exclusion criteria (3 listed)
- Uncorrected visual disorders with non-degenerative etiology (AV<0.5)
- Person under the protection of justice
- Pregnant women (a pregnancy test will be performed in premenopausal women)
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 |
|---|---|---|
| Recognition of objects* Name of shapes / colors / images / objects * Classification of shapes / colors / images / objects | Behavioural | Recognition of objects |
| Location of objects* Search for frequent/rarse targets among distractors sharing one or more characteristics with the target * Hit/catch a stationary/mobile target as quickly as possible | Behavioural | Location of objects |
| Manipulation of objects* Storage of shapes/objects * Use of everyday objects (pen, cutlery, etc.) | Behavioural | Manipulation of objects |
Primary outcome
Effectiveness evaluation
Time frame: At week 34
Effectiveness will be evaluated a score based on success rate (from 0 to 10), reaction time and eye-recording .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 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.
MOUTON Aurélie, Ph principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recognition of objects, Location of objects and Manipulation of objects in people with Posterior Cortical Atrophy, run by Centre Hospitalier Universitaire de Nice 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 7 inclusion and 3 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 22 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effectiveness evaluation (time frame: At week 34). 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 22 Mar 2023.