Clinical trial NCT01329484: Computerized Personal Interventions for Alzheimer's Patients
Official title: Computerized Personal Interventions for Alzheimer's Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer's Disease
Keywords: Alzheimer
Dementia
Computer
Cognitive training
Reminiscence therapy
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2011-04-06
Enrollment: 159
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Visual impairment
* Auditory impairment
* Psychiatric disorders

Primary outcomes:
measure: Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument.
timeFrame: baseline
measure: Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument.
timeFrame: Baseline+1 month
measure: Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument.
timeFrame: Baseline+3 months
measure: Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument.
timeFrame: Baseline+6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Mental Health Center
city: Jerusalem
country: Israel
facility: Memory Clinic, Shaare Zedek Medical Center
Study officials:
affiliation: Mental Health Center, Beer-Sheva
name: Tzvi Dwolatzky, MD
role: PRINCIPAL_INVESTIGATOR
References: