Computerized Personal Interventions for Alzheimer's Patients
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|ClinicalTrials.gov Identifier: NCT01329484|
Recruitment Status : Unknown
Verified February 2011 by Shaare Zedek Medical Center.
Recruitment status was: Enrolling by invitation
First Posted : April 6, 2011
Last Update Posted : April 6, 2011
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Behavioral: Reminiscence therapy Behavioral: Cognitive training Other: No treatment||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||159 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Computerized Personal Interventions for Alzheimer's Patients|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||September 2012|
|Estimated Study Completion Date :||September 2012|
|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
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.
- Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument. [ Time Frame: baseline ]
- Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument. [ Time Frame: Baseline+1 month ]
- Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument. [ Time Frame: Baseline+3 months ]
- Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument. [ Time Frame: Baseline+6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01329484
|Mental Health Center|
|Beer Sheva, Israel|
|Memory Clinic, Shaare Zedek Medical Center|
|Principal Investigator:||Tzvi Dwolatzky, MD||Mental Health Center, Beer-Sheva|