Computerized Personal Interventions for Alzheimer's Patients

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT01329484
First received: March 30, 2011
Last updated: April 3, 2011
Last verified: February 2011
  Purpose

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 Intervention
Alzheimer's Disease
Behavioral: Reminiscence therapy
Behavioral: Cognitive training
Other: No treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Computerized Personal Interventions for Alzheimer's Patients

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument. [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument. [ Time Frame: Baseline+1 month ] [ Designated as safety issue: No ]
  • Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument. [ Time Frame: Baseline+3 months ] [ Designated as safety issue: No ]
  • Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument. [ Time Frame: Baseline+6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 159
Study Start Date: March 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Visual impairment
  • Auditory impairment
  • Psychiatric disorders
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329484

Locations
Israel
Mental Health Center
Beer Sheva, Israel
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
  More Information

No publications provided

Responsible Party: Dr. Tzvi Dwolatzky, Mental Health Center, Beer-Sheva
ClinicalTrials.gov Identifier: NCT01329484     History of Changes
Other Study ID Numbers: CPI-AD-TD-CTIL
Study First Received: March 30, 2011
Last Updated: April 3, 2011
Health Authority: Israel: Research monitoring committee, Mental Health Center, Beer-Sheva.

Keywords provided by Shaare Zedek Medical Center:
Alzheimer
Dementia
Computer
Cognitive training
Reminiscence therapy

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 29, 2014