Life From Vision in Alzheimer Disease

NCT00838942 | Completed

• 1 other identifier: P 010110
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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; Cataract extraction in Alzheimer disease patient

Outcome Measures

Primary Outcomes (1)

• Improvement score of the NPI (Neuropsychiatric Inventory). The improvement is based on the increase by 1 point on the score of NPI

  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).

  3 month after cataract surgery

Study Arms (1)

1

Patients suffering from both Alzheimer's disease and low vision due to a bilateral impeding cataract.

Behavioral: Questionaries

Interventions

Questionaries BEHAVIORAL

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.

1

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients studied are elderly people suffering from both Alzheimer's disease and low vision due to a bilateral impeding cataract

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital Tenon, Service Ophtalmologie

Paris, 75020, France

Location

MeSH Terms

Conditions

Alzheimer Disease; Cataract; Dementia; Hallucinations

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Lens Diseases; Eye Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Brigitte GIRARD, MD PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: February 9, 2009
• Study Start: December 1, 2004
• Primary Completion: March 1, 2011
• Study Completion: April 1, 2011
• Last Updated: October 28, 2011

Record last verified: 2011-06

Locations

FR (1)