Computerized Personal Interventions for Alzheimer's Patients

Sponsor
Shaare Zedek Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01329484
Collaborator
(none)
159
2
3
18.1
79.5
4.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Reminiscence therapy
  • Behavioral: Cognitive training
  • Other: No treatment
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
159 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Computerized Personal Interventions for Alzheimer's Patients
Study Start Date :
Mar 1, 2011
Anticipated Primary Completion Date :
Sep 1, 2012
Anticipated Study Completion Date :
Sep 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cognitive training

Behavioral: Cognitive training
Cognitive training using a computerized system

Experimental: Reminiscence therapy

Behavioral: 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

Other: No treatment
Participants in the control group will receive neither of the 2 experimental interventions or any other similar interventions.

Outcome Measures

Primary Outcome Measures

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

  2. Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument. [Baseline+1 month]

  3. Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument. [Baseline+3 months]

  4. Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument. [Baseline+6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Clinical diagnosis of Alzheimer's Disease

  • MMSE score of 14-26

Exclusion Criteria:
  • Visual impairment

  • Auditory impairment

  • Psychiatric disorders

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mental Health Center Beer Sheva Israel
2 Memory Clinic, Shaare Zedek Medical Center Jerusalem Israel

Sponsors and Collaborators

  • Shaare Zedek Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01329484
Other Study ID Numbers:
  • CPI-AD-TD-CTIL
First Posted:
Apr 6, 2011
Last Update Posted:
Apr 6, 2011
Last Verified:
Feb 1, 2011
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2011