Alzheimer DiseaseVIVANCT00838942
Life From Vision in Alzheimer Disease
An observational study of Alzheimer Disease and Cataract, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The VIVA study is focused on Alzheimer's disease patients with a low vision due to a bilateral cataract. The aim is to study cataract surgery results on patients' autonomy, behaviour, and mood. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease, Cataract
- What is being tested?
- Questionaries
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2004to Apr 2011
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients studied are elderly people suffering from both Alzheimer's disease and low vision due to a bilateral impeding cataract
Who may be able to join
- Signed informed patient's or representative consent for the study
- Patients over 50 years old
- Patients whose bilateral visual acuity is less than 5/10, requiring cataract surgery
- Patients suffering from Alzheimer's disease whose MMS score test is between 10 and 25 (10<MMS≤25)
Who cannot join
- Patient's or representative's refusal
- NEURO-ocular disease resulting in a severe vision impairment
- Severe and evolving disease involving vital prognosis at short term
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cataract Surgery Benefice in Improvement of Behaviour, Autonomy and Mood for Alzheimer Patients.
The VIVA study is focused on Alzheimer's disease patients with a low vision due to a bilateral cataract. The aim is to study cataract surgery results on patients' autonomy, behaviour, and mood. In fact those dement elderly patients suffer from a progressive loss of superior functions, with loss of autonomy, behaviour and mood degradation, associated with physical disabilities. The work hypothesis is that a loss of sensorial functions, particularly visual, is an aggravating factor of NEURO-cognitive troubles and absence of communication with outside circle. The protocol consists in investigating superior functions, autonomy, and behaviour troubles of the participating patients, with the help of a series of neuropsychological tests used one month before and three months after cataract operation on the eye with the worst vision. Independently of the study, patients must have given an informed consent to cataract surgery. Their participation lasts 4 months+/- 1 month. The aim of the study is to evaluate whether the cataract surgery improves patients' behaviour, autonomy and mood and possibly to show evidence onf drawbacks in of such a practice.The main objective targets to cataract surgery benefice on patients suffering from both Alzheimer's disease and impeding cataract, aiming to improve behaviour troubles. The specific objective is to measure this benefice in correlation with visual acuity improvement.
Read the detailed description
VIVA study aims to evaluate cataract surgery results on Alzheimer patients regarding behavior, autonomy and mood. Patients studied are elderly people suffering from both Alzheimer's disease and low vision due to a bilateral impeding cataract. Designed patients come from Ile-de-France-area geriatrics departments.
Methods: the trial consists in a series of neuropsychological tests involving both subject of the study and a close parent one-month before and three months after surgery of the most affected eye. Each patient is under investigation during 4+/1 months. The tests used are the MMS (Mini Mental Status), ADAS-cog Alzheimer Disease Assessment Scale for cognitive functions, NPI (Neuropsychiatric Inventory) for behavior troubles, IADL (Instrumental Activities of Daily) for autonomy evaluation, GDS (Geriatric Depression Scale) or Cornell Scale (Cornell Scale for Depression in Dementia) for mood troubles. All data are registered along as well as medical treatments and severe side effects.
Practical method:An ophthalmologic surgery department head operates on the patients at National Ophthalmologic Hospital "QUINZE VINGT" in Paris.The surgery involves the eye with the worst vision. Study analysis does not take into account the results of the second eye intervention. The surgery consists in a phacoemulsification and setting of an acrylic implant in the posterior chamber. Patients care consists in the usual procedures. The intervention is performed under regional anesthesia exceptionally general anesthesia. A three-day hospitalization is regular considering patients' fragility.The aim of the study is to analyze 3 months after cataract surgery, the different neuropsychological tests, with the help of appropriate statistics. The main endpoint criterion will be the NPI-test improvement between the one-month test before surgery and the three-month test after. A correlation between visual acuity improvement and NPI-test improvement will be verified. The second endpoint criterion will be the study of other scores (MMS, IADL, ADAS-cog, GDS or Cornell test), in a matched-way. If improvement is noted, a regression logistic study will permit to study improvement predictive factors. Each participant will take part in the study during 4+/-1 months.Study rationale and literature data abstract.Cataract treatment, restoring a better visual function, is greatly beneficial upon life quality of elderly people, as largely demonstrated (1, 2). Several studies, based on cognitive functions, daily life activities, and mood, showed a significant amelioration of elderly people operated on for cataract, in comparison with those who refused the intervention (3). Benefice is less in case of ocular co morbidity or in some very old patients (4).Cataract surgery on elderly patients suffering from cognitive decline has given rise to very few studies. Nevertheless, correlation between low vision and cognitive alteration is well established. In France, a Health High Authority (HHA) report devoted to cataract surgical treatment evaluation, based on literature data and experts opinion, was published in 2000 (6). The report dealt with the taking in care of demented or low mental capacities patients. It regretted that very few trials were undertaken for this problem.. In case of beginning dementia, the experts thought that cataract surgery visual benefice is limited. It seldom improves lecture but allows patients to watch television more and makes contacts with neighbors easier. In case of advanced dementia, the authors thought that surgery would worsen rapidly patients. The report evoked as well the paternalistic decisions taken without any dialogue with the involved patient and raised ethical issues. Still to-day, in case of dementia, the cataract management remains an actual problem. This is a challenge for closes, guardians, geriatrics', ophthalmologists and sometimes the decision is opposed to patients' feelings (8).One of the studies cited in the HHA report, based on few low-vision patients, showed after cataract surgery, a light improvement of mental status, everyday life but poor results on depression. After surgery, patients felt that they were not as fragile as they had thought, that they endured the operation and felt better after (9). In 2003, a Japanese study dealt with cognitive functions of 40 demented patients suffering from cataract. Results and showed that among the 20 patients who chose to be operated on, 60% were improved, 35% were unchanged, and 5% worsened (10). By extensive neuropsychological investigations on Alzheimer' patients, the VIVA study would show the impact of visual function improvement on cognitive functions, psychological and behavioural troubles, autonomy, and mood perturbations. Pointing out the objectives upon improvement of neuropsychiatric survey, namely the NPI test, the study would permit to precise the low-vision cataract role on patients' comportment troubles which are a cause of burn-out for caring people. It is clearly demonstrated that delirious manifestations, notably visual hallucinations are frequent in demented persons and in patients with low vision as well (9). In low-vision patients, it seems that only the cataract is significantly linked to visual hallucinations (10). The VIVA study aims to show also the benefice of a better visual function on behavioural non-disturbing troubles such as apathy and inhibition. Therefore, we would like to stress the cataract management benefits on Alzheimer's disease patients. Particularly, we intend to precise the extent of expected patients' improvement and to measure the correlation with visual acuity improvement
- Conditions
- Alzheimer Disease, Cataract
- Being tested
- Questionaries
- Keywords
- Eyes disease and dementia., Cataract surgery in the patient with dementia., Visual hallucinations, Visual acuity,, Specific eye pathologies in Alzheimer's disease., Improvement of behaviour,, Improvement of autonomy, Improvement of mood, Cataract extraction in Alzheimer disease patient
- Medical subject headings
- Alzheimer Disease, Cataract, Dementia, Hallucinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionariesBehavioural
MMS (Mini Mental Status), ADAS-cog Alzheimer Disease Assessment Scale for cognitive functions, NPI (Neuropsychiatric Inventory) for behavior troubles, IADL (Instrumental Activities of Daily) for autonomy evaluation, GDS (Geriatric Depression Scale) or Cornell Scale (Cornell Scale for Depression in Dementia) for mood troubles.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients suffering from both Alzheimer's disease and low vision due to a bilateral impeding cataract. Receives: Behavioral: Questionaries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement score of the NPI (Neuropsychiatric Inventory). The improvement is based on the increase by 1 point on the score of NPI
Measured: 3 month after cataract surgery
Secondary outcomes (1)
Improvement score of MMS(Mini mental status), of ADAS-COG(Alzheimer disease Assessment scale for cognitive function), IADL(Instrumental activity on daily) and GDS(Geriatric depression scale).
Measured: 3 month after cataract surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2009 (estimated)
- Study startDec 2004
- Primary completionMar 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brigitte GIRARD, MD PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838942
- Sponsor's protocol ID
- P 010110
- Acronym
- VIVA
- Status last verified
- Jun 2011
- First submitted
- 6 Feb 2009
- Last updated
- 28 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cataract Surgery Benefice in Improvement of Behaviour, Autonomy and Mood for Alzheimer Patients.
- ClinicalTrials.gov ID
- NCT00838942
- Acronym / sponsor ID
- VIVA / P 010110
- Conditions
- Alzheimer Disease, Cataract
- Keywords
- Eyes disease and dementia., Cataract surgery in the patient with dementia., Visual hallucinations, Visual acuity,, Specific eye pathologies in Alzheimer's disease., Improvement of behaviour,, Improvement of autonomy, Improvement of mood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 9 Feb 2009 (estimated)
- 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.
The VIVA study is focused on Alzheimer's disease patients with a low vision due to a bilateral cataract. The aim is to study cataract surgery results on patients' autonomy, behaviour, and mood. In fact those dement elderly patients suffer from a progressive loss of superior functions, with loss of autonomy, behaviour and mood degradation, associated with physical disabilities. The work hypothesis is that a loss of sensorial functions, particularly visual, is an aggravating factor of NEURO-cognitive troubles and absence of communication with outside circle. The protocol consists in investigating superior functions, autonomy, and behaviour troubles of the participating patients, with the help of a series of neuropsychological tests used one month before and three months after cataract operation on the eye with the worst vision. Independently of the study, patients must have given an informed consent to cataract surgery. Their participation lasts 4 months+/- 1 month. The aim of the study is to evaluate whether the cataract surgery improves patients' behaviour, autonomy and mood and possibly to show evidence onf drawbacks in of such a practice.The main objective targets to cataract surgery benefice on patients suffering from both Alzheimer's disease and impeding cataract, aiming to improve behaviour troubles. The specific objective is to measure this benefice in correlation with visual acuity improvement.
Detailed description
VIVA study aims to evaluate cataract surgery results on Alzheimer patients regarding behavior, autonomy and mood. Patients studied are elderly people suffering from both Alzheimer's disease and low vision due to a bilateral impeding cataract. Designed patients come from Ile-de-France-area geriatrics departments.
Methods: the trial consists in a series of neuropsychological tests involving both subject of the study and a close parent one-month before and three months after surgery of the most affected eye. Each patient is under investigation during 4+/1 months. The tests used are the MMS (Mini Mental Status), ADAS-cog Alzheimer Disease Assessment Scale for cognitive functions, NPI (Neuropsychiatric Inventory) for behavior troubles, IADL (Instrumental Activities of Daily) for autonomy evaluation, GDS (Geriatric Depression Scale) or Cornell Scale (Cornell Scale for Depression in Dementia) for mood troubles. All data are registered along as well as medical treatments and severe side effects.
Practical method:An ophthalmologic surgery department head operates on the patients at National Ophthalmologic Hospital "QUINZE VINGT" in Paris.The surgery involves the eye with the worst vision. Study analysis does not take into account the results of the second eye intervention. The surgery consists in a phacoemulsification and setting of an acrylic implant in the posterior chamber. Patients care consists in the usual procedures. The intervention is performed under regional anesthesia exceptionally general anesthesia. A three-day hospitalization is regular considering patients' fragility.The aim of the study is to analyze 3 months after cataract surgery, the different neuropsychological tests, with the help of appropriate statistics. The main endpoint criterion will be the NPI-test improvement between the one-month test before surgery and the three-month test after. A correlation between visual acuity improvement and NPI-test improvement will be verified. The second endpoint criterion will be the study of other scores (MMS, IADL, ADAS-cog, GDS or Cornell test), in a matched-way. If improvement is noted, a regression logistic study will permit to study improvement predictive factors. Each participant will take part in the study during 4+/-1 months.Study rationale and literature data abstract.Cataract treatment, restoring a better visual function, is greatly beneficial upon life quality of elderly people, as largely demonstrated (1, 2). Several studies, based on cognitive functions, daily life activities, and mood, showed a significant amelioration of elderly people operated on for cataract, in comparison with those who refused the intervention (3). Benefice is less in case of ocular co morbidity or in some very old patients (4).Cataract surgery on elderly patients suffering from cognitive decline has given rise to very few studies. Nevertheless, correlation between low vision and cognitive alteration is well established. In France, a Health High Authority (HHA) report devoted to cataract surgical treatment evaluation, based on literature data and experts opinion, was published in 2000 (6). The report dealt with the taking in care of demented or low mental capacities patients. It regretted that very few trials were undertaken for this problem.. In case of beginning dementia, the experts thought that cataract surgery visual benefice is limited. It seldom improves lecture but allows patients to watch television more and makes contacts with neighbors easier. In case of advanced dementia, the authors thought that surgery would worsen rapidly patients. The report evoked as well the paternalistic decisions taken without any dialogue with the involved patient and raised ethical issues. Still to-day, in case of dementia, the cataract management remains an actual problem. This is a challenge for closes, guardians, geriatrics', ophthalmologists and sometimes the decision is opposed to patients' feelings (8).One of the studies cited in the HHA report, based on few low-vision patients, showed after cataract surgery, a light improvement of mental status, everyday life but poor results on depression. After surgery, patients felt that they were not as fragile as they had thought, that they endured the operation and felt better after (9). In 2003, a Japanese study dealt with cognitive functions of 40 demented patients suffering from cataract. Results and showed that among the 20 patients who chose to be operated on, 60% were improved, 35% were unchanged, and 5% worsened (10). By extensive neuropsychological investigations on Alzheimer' patients, the VIVA study would show the impact of visual function improvement on cognitive functions, psychological and behavioural troubles, autonomy, and mood perturbations. Pointing out the objectives upon improvement of neuropsychiatric survey, namely the NPI test, the study would permit to precise the low-vision cataract role on patients' comportment troubles which are a cause of burn-out for caring people. It is clearly demonstrated that delirious manifestations, notably visual hallucinations are frequent in demented persons and in patients with low vision as well (9). In low-vision patients, it seems that only the cataract is significantly linked to visual hallucinations (10). The VIVA study aims to show also the benefice of a better visual function on behavioural non-disturbing troubles such as apathy and inhibition. Therefore, we would like to stress the cataract management benefits on Alzheimer's disease patients. Particularly, we intend to precise the extent of expected patients' improvement and to measure the correlation with visual acuity improvement
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: QuestionariesPatients suffering from both Alzheimer's disease and low vision due to a bilateral impeding cataract. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients studied are elderly people suffering from both Alzheimer's disease and low vision due to a bilateral impeding cataract
Key inclusion criteria (4 listed)
- Signed informed patient's or representative consent for the study
- Patients over 50 years old
- Patients whose bilateral visual acuity is less than 5/10, requiring cataract surgery
- Patients suffering from Alzheimer's disease whose MMS score test is between 10 and 25 (10<MMS≤25)
Key exclusion criteria (3 listed)
- Patient's or representative's refusal
- NEURO-ocular disease resulting in a severe vision impairment
- Severe and evolving disease involving vital prognosis at short term
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 |
|---|---|---|
| QuestionariesMMS (Mini Mental Status), ADAS-cog Alzheimer Disease Assessment Scale for cognitive functions, NPI (Neuropsychiatric Inventory) for behavior troubles, IADL (Instrumental Activities of Daily) for autonomy evaluation, GDS (Geriatric Depression Scale) or Cornell Scale (Cornell Scale for Depression in Dementia) for mood troubles. | Behavioural | 1 |
Primary outcome
Improvement score of the NPI (Neuropsychiatric Inventory). The improvement is based on the increase by 1 point on the score of NPI
Time frame: 3 month after cataract surgery
1 secondary outcome
Improvement score of MMS(Mini mental status), of ADAS-COG(Alzheimer disease Assessment scale for cognitive function), IADL(Instrumental activity on daily) and GDS(Geriatric depression scale).
Time frame: 3 month after cataract surgery
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 28 Oct 2011.
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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.
Brigitte GIRARD, MD PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Cataract, run by Assistance Publique - Hôpitaux de Paris 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 4 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 28 Oct 2011. 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?
Improvement score of the NPI (Neuropsychiatric Inventory). The improvement is based on the increase by 1 point on the score of NPI (time frame: 3 month after cataract surgery). 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 28 Oct 2011.