Computerized Personal Interventions for Alzheimer's Patients

NCT ID: NCT01329484

Last Updated: 2011-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-09-30

Brief Summary

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The purpose of this study is to determine whether the use of computerized systems in 2 common non pharmacological therapies (cognitive training and reminiscence therapy) will improve the cognitive function of patients with mild to moderate Alzheimer's disease (AD), or at least delay its deterioration. In addition, the investigators hypothesize that using the computerized systems will result in improved well-being of the patients and their main caregivers / family members, and in improved patient-caregiver and patient-family relations.

Detailed Description

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Reminiscence therapy and cognitive training are two of the most common non-pharmacological therapies used to treat AD. To date, there is no clear evidence regarding the impact of these treatments on the cognitive function of people with AD. The inconclusive evidence may be due to methodological limitations, the availability of a limited number of controlled studies, the lack of standardized interventions and the need for sensitive assessment tools.

Increasingly, computerized systems are being designed to support both the cognitive assessment of patients with Alzheimer's disease and the administration of novel non-pharmacological interventions. Studies suggest that such systems may be of clear benefit. For example, in an initial study involving patients with AD, computerized cognitive training systems have been shown to be of value in providing a more standardized approach to cognitive training. Also, another study found that the use of a computerized system for reminiscence therapy was successful in facilitating patient-caregiver interaction.

Our research is a collaborative effort designed to test the effects of two such computer-supported interventions in patients with mild AD. The purpose of the research is to compare the efficacy of personalized computerized reminiscence therapy and that of computerized cognitive training to a control group. The reminiscence therapy program is based on developing an internet-based personalized reminiscence system, which will facilitate flexible interactive use by patients and caregivers. The importance of a personalized system is especially salient in immigrant, or in highly mobile, societies due to the heterogeneous background of the patients.

Separate preliminary studies have found positive effects of each system. The research will use various measures to evaluate the efficacy of both treatments, including the Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument, which will serve as the cognitive outcome measure.

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cognitive training

Group Type EXPERIMENTAL

Cognitive training

Intervention Type BEHAVIORAL

Cognitive training using a computerized system

Reminiscence therapy

Group Type EXPERIMENTAL

Reminiscence therapy

Intervention Type BEHAVIORAL

Personalized reminiscence therapy using a computerized system

Control

This group will receive neither of the above interventions or any other similar interventions

Group Type OTHER

No treatment

Intervention Type OTHER

Participants in the control group will receive neither of the 2 experimental interventions or any other similar interventions.

Interventions

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Reminiscence therapy

Personalized reminiscence therapy using a computerized system

Intervention Type BEHAVIORAL

Cognitive training

Cognitive training using a computerized system

Intervention Type BEHAVIORAL

No treatment

Participants in the control group will receive neither of the 2 experimental interventions or any other similar interventions.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of Alzheimer's Disease
* MMSE score of 14-26

Exclusion Criteria

* Visual impairment
* Auditory impairment
* Psychiatric disorders
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Mental Health Center, Beer-Sheva

Principal Investigators

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Tzvi Dwolatzky, MD

Role: PRINCIPAL_INVESTIGATOR

Mental Health Center, Beer-Sheva

Locations

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Mental Health Center

Beersheba, , Israel

Site Status

Memory Clinic, Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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CPI-AD-TD-CTIL

Identifier Type: -

Identifier Source: org_study_id

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