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Computerized Personal Interventions for Alzheimer's Patients

Primary Purpose

Alzheimer's Disease

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Reminiscence therapy
Cognitive training
No treatment
Sponsored by
Shaare Zedek Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer, Dementia, Computer, Cognitive training, Reminiscence therapy

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Visual impairment
  • Auditory impairment
  • Psychiatric disorders

Sites / Locations

  • Mental Health Center
  • Memory Clinic, Shaare Zedek Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Cognitive training

Reminiscence therapy

Control

Arm Description

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

Outcomes

Primary Outcome Measures

Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument.
Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument.
Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument.
Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument.

Secondary Outcome Measures

Full Information

First Posted
March 30, 2011
Last Updated
April 3, 2011
Sponsor
Shaare Zedek Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01329484
Brief Title
Computerized Personal Interventions for Alzheimer's Patients
Official Title
Computerized Personal Interventions for Alzheimer's Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
September 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shaare Zedek Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer, Dementia, Computer, Cognitive training, Reminiscence therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
159 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive training
Arm Type
Experimental
Arm Title
Reminiscence therapy
Arm Type
Experimental
Arm Title
Control
Arm Type
Other
Arm Description
This group will receive neither of the above interventions or any other similar interventions
Intervention Type
Behavioral
Intervention Name(s)
Reminiscence therapy
Intervention Description
Personalized reminiscence therapy using a computerized system
Intervention Type
Behavioral
Intervention Name(s)
Cognitive training
Intervention Description
Cognitive training using a computerized system
Intervention Type
Other
Intervention Name(s)
No treatment
Intervention Description
Participants in the control group will receive neither of the 2 experimental interventions or any other similar interventions.
Primary Outcome Measure Information:
Title
Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument.
Time Frame
baseline
Title
Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument.
Time Frame
Baseline+1 month
Title
Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument.
Time Frame
Baseline+3 months
Title
Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument.
Time Frame
Baseline+6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of Alzheimer's Disease MMSE score of 14-26 Exclusion Criteria: Visual impairment Auditory impairment Psychiatric disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tzvi Dwolatzky, MD
Organizational Affiliation
Mental Health Center, Beer-Sheva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mental Health Center
City
Beer Sheva
Country
Israel
Facility Name
Memory Clinic, Shaare Zedek Medical Center
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

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Computerized Personal Interventions for Alzheimer's Patients

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