Computerized Personal Interventions for Alzheimer's Patients
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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 |
- 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 |
Inclusion Criteria:
- Clinical diagnosis of Alzheimer's Disease
- MMSE score of 14-26
Exclusion Criteria:
- Visual impairment
- Auditory impairment
- Psychiatric disorders
Contacts and Locations| Israel | |
| Mental Health Center | |
| Beer Sheva, Israel | |
| Memory Clinic, Shaare Zedek Medical Center | |
| Jerusalem, Israel | |
| 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 May 23, 2013