- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01329484
Computerized Personal Interventions for Alzheimer's Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Beer Sheva, Israel
- Mental Health Center
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Jerusalem, Israel
- Memory Clinic, Shaare Zedek Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of Alzheimer's Disease
- MMSE score of 14-26
Exclusion Criteria:
- Visual impairment
- Auditory impairment
- Psychiatric disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive training
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Cognitive training using a computerized system
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Experimental: Reminiscence therapy
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Personalized reminiscence therapy using a computerized system
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Other: Control
This group will receive neither of the above interventions or any other similar interventions
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Participants in the control group will receive neither of the 2 experimental interventions or any other similar interventions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument.
Time Frame: baseline
|
baseline
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Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument.
Time Frame: Baseline+1 month
|
Baseline+1 month
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Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument.
Time Frame: Baseline+3 months
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Baseline+3 months
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Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument.
Time Frame: Baseline+6 months
|
Baseline+6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tzvi Dwolatzky, MD, Mental Health Center, Beer-Sheva
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPI-AD-TD-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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