Computerized Personal Interventions for Alzheimer's Patients

April 3, 2011 updated by: Shaare Zedek Medical Center
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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

159

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Beer Sheva, Israel
        • Mental Health Center
      • Jerusalem, Israel
        • Memory Clinic, Shaare Zedek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Visual impairment
  • Auditory impairment
  • Psychiatric disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive training
Cognitive training using a computerized system
Experimental: Reminiscence therapy
Personalized reminiscence therapy using a computerized system
Other: Control
This group will receive neither of the above interventions or any other similar interventions
Participants in the control group will receive neither of the 2 experimental interventions or any other similar interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument.
Time Frame: baseline
baseline
Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument.
Time Frame: Baseline+1 month
Baseline+1 month
Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument.
Time Frame: Baseline+3 months
Baseline+3 months
Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument.
Time Frame: Baseline+6 months
Baseline+6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Tzvi Dwolatzky, MD, Mental Health Center, Beer-Sheva

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

September 1, 2012

Study Completion (Anticipated)

September 1, 2012

Study Registration Dates

First Submitted

March 30, 2011

First Submitted That Met QC Criteria

April 3, 2011

First Posted (Estimate)

April 6, 2011

Study Record Updates

Last Update Posted (Estimate)

April 6, 2011

Last Update Submitted That Met QC Criteria

April 3, 2011

Last Verified

February 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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