Clinical trial NCT02521558: Effectiveness of Home-based Electronic Cognitive Therapy in Alzheimer's Disease
Official title: Effectiveness of Home-based Electronic Cognitive Therapy in Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Memory Disorders
Mild Cognitive Impairment
Alzheimer's Disease
Keywords: Cognitive rehabilitation
Mobile electronic application
Memory tasks
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Wallace H. Coulter Foundation
First posted: 2015-08-13
Enrollment: 30
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current study will examine the use of a mobile electronic application used to deliver cognitive rehabilitation to patients with mild cognitive impairment due (MCI) due to Alzheimer's disease (AD), and patients with mild AD. Patients will be given a specific cognitive rehabilitation program on their mobile device (iPad) with specific tasks for them to complete. The goal of this study is to determine if a) patients are able to use and adhere to a cognitive rehabilitation program delivered to their mobile device and b) to determine if patients can improve their language, attention, and memory by completing cognitive rehabilitation tasks assigned to them.

Detailed description: In the current study, the investigators are examining the use of a mobile electronic application used to deliver cognitive rehabilitation tasks to patients with mild cognitive impairment due to Alzheimer's disease, and patients with mild Alzheimer's disease. An estimated 100 patients will be enrolled into the study (\~50 patients with mild cognitive impairment, \~50 patients with Alzheimer's disease).

Participants will either receive memory tasks designed to help stabilize or improve memory (Intervention Group) or a set of word or math puzzles (Control Group). Participants will complete memory tasks or puzzles for a six month period. The investigators will conduct pre- and post- neuropsychological testing to assess changes in cognitive status (e.g., memory, language, executive functioning) in the intervention group. Neuropsychological tests assessing changes to cognition will be completed prior to participant assignment to the Intervention or Control Group. Both groups will then be assessed again using neuropsychological tests. The investigators will also assess changes in performance on cognitive rehabilitation tests over the six month period to determine the efficacy of these tasks.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of mild cognitive impairment due to Alzheimer's disease (MCI due to AD) by the patient's referring clinician per recent National Institutes of Aging-Alzheimer's Association criteria (Albert et al., 2011).
* A diagnosis of mild Alzheimer's disease by the patient's referring clinician per recent National Institutes of Aging-Alzheimer's Association criteria (McKhann et al., 2011).
* 50-90 years of age.

Exclusion Criteria:

* Younger than the age of 50 or older than the age of 90.
* Any self-reported history of substance abuse or alcohol abuse.
* Any self-reported history of prior head trauma (e.g., stroke, traumatic brain injury)
* Any prior self-reported history of significant depression or other mood disorder.

Primary outcomes:
measure: Changes in cognition as measured by the Mini Mental Status Exam
timeFrame: Month 0 (Prior to administration of cognitive rehabilitation tasks) and Month 6 (after administration of cognitive rehabilitation tasks)
measure: Changes in cognition as measured by the Montreal Cognitive Assessment
timeFrame: Month 0 (Prior to administration of cognitive rehabilitation tasks) and Month 6 (after administration of cognitive rehabilitation tasks)
measure: Changes in cognition as measured by the Consortium to Establish a Registry in Alzheimer's disease Word List Test
timeFrame: Month 0 (Prior to administration of cognitive rehabilitation tasks) and Month 6 (after administration of cognitive rehabilitation tasks)
measure: Changes in cognition as measured Letter and Category Fluency
timeFrame: Month 0 (Prior to administration of cognitive rehabilitation tasks) and Month 6 (after administration of cognitive rehabilitation tasks)
measure: Changes in cognition as measured by the Boston Naming Test (Short Form)
timeFrame: Month 0 (Prior to administration of cognitive rehabilitation tasks) and Month 6 (after administration of cognitive rehabilitation tasks)
measure: Changes in cognition as measured by the Trail Making Parts A & B
timeFrame: Month 0 (Prior to administration of cognitive rehabilitation tasks) and Month 6 (after administration of cognitive rehabilitation tasks)
Secondary outcomes:
measure: Changes in performance on cognitive rehabilitation tasks (composite measure of memory tasks)
timeFrame: During intervention (6 month time frame, composite measure)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
Study officials:
affiliation: Boston University
name: Andrew E Budson, MD
role: PRINCIPAL_INVESTIGATOR
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