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Effectiveness of Home-based Electronic Cognitive Therapy in Alzheimer's Disease (CTAD)

Primary Purpose

Memory Disorders, Mild Cognitive Impairment, Alzheimer's Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention Group
Control Group
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Memory Disorders focused on measuring Cognitive rehabilitation, Mobile electronic application, Memory tasks

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Boston University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control Group

Arm Description

In the Intervention Group, patients will receive an iPad with the Constant Therapy cognitive rehabilitation application. Patients in the Intervention Group will practice the memory tasks developed for the Constant Therapy application for a total of six months. On a weekly basis, a clinician and/or research assistant will check in with the patient to answer any questions or address any concerns the patient has with using the Constant Therapy application, or how to perform any of the memory tasks. At the end of six months, each individual in the Intervention Group is assessed with standard cognitive testing to determine if there was any change on overall cognition.

The Control Group will not receive any intervention. The Control Group will be given simple sets of puzzle booklets to practice over the 6 month period (e.g., word search puzzles, number and/or math puzzles). The Control Group will also receive standardized cognitive testing at the end of 6 months. Weekly check-ins by a clinician and/or research assistant will also occur in the Control Group. Every 4th patient recruited for the study will be assigned to the Control Group.

Outcomes

Primary Outcome Measures

Changes in cognition as measured by the Mini Mental Status Exam
Participants will be administered the Mini Mental Status Exam (MMSE) to both the intervention and control groups. This will occur prior to any to type of intervention (Month 0). Scores on the MMSE range from 0 to 30. Specifically the investigators are examining if cognitive status changes as measured by the MMSE prior to intervention (Month 0), and post-intervention (Month 6). The investigators will compare changes in MMSE scores both pre- and post- in the intervention group, but also compare performance on these measures to the control group.
Changes in cognition as measured by the Montreal Cognitive Assessment
Participants will be administered the Montreal Cognitive Assessment (MoCA) to both the intervention and control groups. This will occur prior to any to type of intervention (Month 0). Scores on the MoCA range from 0 to 30. Specifically the investigators are examining if cognitive status changes as measured by the MoCA prior to intervention (Month 0), and post-intervention (Month 6). The investigators will compare changes in MoCA scores both pre- and post- in the intervention group, but also compare performance on these measures to the control group.
Changes in cognition as measured by the Consortium to Establish a Registry in Alzheimer's disease Word List Test
Participants will be administered the Consortium to Establish a Registry in Alzheimer's disease Word List Learning Test (CERAD) to both the intervention and control groups. This will occur prior to any to type of intervention (Month 0). The CERAD measures the immediate recall of a list of words (up to 30 correct recall on 3 individual recall trials), delayed recall (up to 10 correct recall after a 5 minute delay), and on yes-no recognition memory (up to 10 correct recognition). Specifically the investigators are examining if list learning changes as measured by the CERAD prior to intervention (Month 0), and post-intervention (Month 6). The investigators will compare changes in CERAD scores both pre- and post- in the intervention group, but also compare performance on these measures to the control group.
Changes in cognition as measured Letter and Category Fluency
Participants will be administered the Letter and Category Fluency to both the intervention and control groups. This will occur prior to any to type of intervention (Month 0). For letter fluency, participants name as many words as possible in a minute that start with the letters F, A, and S. For category fluency, participants name as many words as possible in a minute that are within the Animals, Vegetables, and Fruits categories. Specifically the investigators are examining if fluency changes as measured by the fluency prior to intervention (Month 0), and post-intervention (Month 6). The investigators will compare changes in fluency scores both pre- and post- in the intervention group, but also compare performance on these measures to the control group.
Changes in cognition as measured by the Boston Naming Test (Short Form)
Participants will be administered the Boston Naming Testing Short Form (BNT-15) to both the intervention and control groups. This will occur prior to any to type of intervention (Month 0). The BNT-15 consists of 15 line drawings (with a maximum score of 15 correct). Specifically the investigators are examining if confrontation naming of line drawings as measured by the BNT-15 prior to intervention (Month 0), and post-intervention (Month 6). The investigators will compare changes in fluency scores both pre- and post- in the intervention group, but also compare performance on these measures to the control group.
Changes in cognition as measured by the Trail Making Parts A & B
Participants will be administered the Trail Making Test (Parts A & B) to both the intervention and control groups. This will occur prior to any to type of intervention (Month 0). The Trail Making Test Part A consists of connecting a series a numbers with a line in ascending order as quickly as possible (performance is timed, the score is the time it takes to finish). The Trail Making Test Part B consists of connect a series of letters and numbers, alternating back and forth between them, as quickly as possible in ascending order (performance is timed, the score is the time it takes to finish). Specifically the investigators are examining if Trail Making performance as measured by the Trail Making Tests prior to intervention (Month 0), and post-intervention (Month 6). The investigators will compare changes in fluency scores both pre- and post- in the intervention group, but also compare performance on these measures to the control group.

Secondary Outcome Measures

Changes in performance on cognitive rehabilitation tasks (composite measure of memory tasks)
In the intervention group, the investigators will examine speed and accuracy data on all cognitive rehabilitation memory tasks. Tasks will be converted into a single memory composite measure (for both speed and accuracy data). The investigators will cull performance on the tasks on a weekly basis. Weekly data will be treated as a single data points. Participants will be followed for approximately 24 weeks (or 6 months). The investigators will use a regression analysis to analyze to determine changes in the slope on speed and accuracy for each of these data points. Additionally, the investigators will use inferential statistics, such as ANOVA, to determine if participants improve on a week by week basis. These analyses will be conducted on the composite of memory data collected from all the memory tasks.

Full Information

First Posted
August 4, 2015
Last Updated
February 2, 2021
Sponsor
Boston University
Collaborators
Wallace H. Coulter Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02521558
Brief Title
Effectiveness of Home-based Electronic Cognitive Therapy in Alzheimer's Disease
Acronym
CTAD
Official Title
Effectiveness of Home-based Electronic Cognitive Therapy in Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Enrollment was halted early because of low adherence to the intervention.
Study Start Date
September 2015 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
Collaborators
Wallace H. Coulter Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Disorders, Mild Cognitive Impairment, Alzheimer's Disease
Keywords
Cognitive rehabilitation, Mobile electronic application, Memory tasks

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
In the Intervention Group, patients will receive an iPad with the Constant Therapy cognitive rehabilitation application. Patients in the Intervention Group will practice the memory tasks developed for the Constant Therapy application for a total of six months. On a weekly basis, a clinician and/or research assistant will check in with the patient to answer any questions or address any concerns the patient has with using the Constant Therapy application, or how to perform any of the memory tasks. At the end of six months, each individual in the Intervention Group is assessed with standard cognitive testing to determine if there was any change on overall cognition.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The Control Group will not receive any intervention. The Control Group will be given simple sets of puzzle booklets to practice over the 6 month period (e.g., word search puzzles, number and/or math puzzles). The Control Group will also receive standardized cognitive testing at the end of 6 months. Weekly check-ins by a clinician and/or research assistant will also occur in the Control Group. Every 4th patient recruited for the study will be assigned to the Control Group.
Intervention Type
Behavioral
Intervention Name(s)
Intervention Group
Intervention Description
The investigators are interested in how practicing memory tasks can improve memory in patients with MCI and with AD. Specifically, patients will perform a set of cognitive rehabilitation tasks designed to train memory in order to determine if these tasks are effective in improving memory or slowing the progression of Alzheimer's disease. Patients will practice memory tasks for about an hour daily, for a total duration of 6 months. A research assistant or clinician will conduct weekly check-ins with each participant assess whether or not participants in the Intervention Group exhibit weekly improvements and to determine if patients are regularly adhering to the tasks.
Intervention Type
Behavioral
Intervention Name(s)
Control Group
Intervention Description
The Control Group will not receive any cognitive rehabilitation tasks for a six month period. Instead, they will simply be given booklets of puzzles (e.g., word search, number puzzles, etc.) to work on for the duration of 6 months. A research assistant or clinician will conduct weekly check-ins with each participant assess whether or not participants in the control group feel like they are benefiting from the puzzles. Participants in the Control Group will be given a standard battery of neuropsychological tests prior to the the puzzles and after the puzzles to assess any changes in memory, language, attention, and executive functioning.
Primary Outcome Measure Information:
Title
Changes in cognition as measured by the Mini Mental Status Exam
Description
Participants will be administered the Mini Mental Status Exam (MMSE) to both the intervention and control groups. This will occur prior to any to type of intervention (Month 0). Scores on the MMSE range from 0 to 30. Specifically the investigators are examining if cognitive status changes as measured by the MMSE prior to intervention (Month 0), and post-intervention (Month 6). The investigators will compare changes in MMSE scores both pre- and post- in the intervention group, but also compare performance on these measures to the control group.
Time Frame
Month 0 (Prior to administration of cognitive rehabilitation tasks) and Month 6 (after administration of cognitive rehabilitation tasks)
Title
Changes in cognition as measured by the Montreal Cognitive Assessment
Description
Participants will be administered the Montreal Cognitive Assessment (MoCA) to both the intervention and control groups. This will occur prior to any to type of intervention (Month 0). Scores on the MoCA range from 0 to 30. Specifically the investigators are examining if cognitive status changes as measured by the MoCA prior to intervention (Month 0), and post-intervention (Month 6). The investigators will compare changes in MoCA scores both pre- and post- in the intervention group, but also compare performance on these measures to the control group.
Time Frame
Month 0 (Prior to administration of cognitive rehabilitation tasks) and Month 6 (after administration of cognitive rehabilitation tasks)
Title
Changes in cognition as measured by the Consortium to Establish a Registry in Alzheimer's disease Word List Test
Description
Participants will be administered the Consortium to Establish a Registry in Alzheimer's disease Word List Learning Test (CERAD) to both the intervention and control groups. This will occur prior to any to type of intervention (Month 0). The CERAD measures the immediate recall of a list of words (up to 30 correct recall on 3 individual recall trials), delayed recall (up to 10 correct recall after a 5 minute delay), and on yes-no recognition memory (up to 10 correct recognition). Specifically the investigators are examining if list learning changes as measured by the CERAD prior to intervention (Month 0), and post-intervention (Month 6). The investigators will compare changes in CERAD scores both pre- and post- in the intervention group, but also compare performance on these measures to the control group.
Time Frame
Month 0 (Prior to administration of cognitive rehabilitation tasks) and Month 6 (after administration of cognitive rehabilitation tasks)
Title
Changes in cognition as measured Letter and Category Fluency
Description
Participants will be administered the Letter and Category Fluency to both the intervention and control groups. This will occur prior to any to type of intervention (Month 0). For letter fluency, participants name as many words as possible in a minute that start with the letters F, A, and S. For category fluency, participants name as many words as possible in a minute that are within the Animals, Vegetables, and Fruits categories. Specifically the investigators are examining if fluency changes as measured by the fluency prior to intervention (Month 0), and post-intervention (Month 6). The investigators will compare changes in fluency scores both pre- and post- in the intervention group, but also compare performance on these measures to the control group.
Time Frame
Month 0 (Prior to administration of cognitive rehabilitation tasks) and Month 6 (after administration of cognitive rehabilitation tasks)
Title
Changes in cognition as measured by the Boston Naming Test (Short Form)
Description
Participants will be administered the Boston Naming Testing Short Form (BNT-15) to both the intervention and control groups. This will occur prior to any to type of intervention (Month 0). The BNT-15 consists of 15 line drawings (with a maximum score of 15 correct). Specifically the investigators are examining if confrontation naming of line drawings as measured by the BNT-15 prior to intervention (Month 0), and post-intervention (Month 6). The investigators will compare changes in fluency scores both pre- and post- in the intervention group, but also compare performance on these measures to the control group.
Time Frame
Month 0 (Prior to administration of cognitive rehabilitation tasks) and Month 6 (after administration of cognitive rehabilitation tasks)
Title
Changes in cognition as measured by the Trail Making Parts A & B
Description
Participants will be administered the Trail Making Test (Parts A & B) to both the intervention and control groups. This will occur prior to any to type of intervention (Month 0). The Trail Making Test Part A consists of connecting a series a numbers with a line in ascending order as quickly as possible (performance is timed, the score is the time it takes to finish). The Trail Making Test Part B consists of connect a series of letters and numbers, alternating back and forth between them, as quickly as possible in ascending order (performance is timed, the score is the time it takes to finish). Specifically the investigators are examining if Trail Making performance as measured by the Trail Making Tests prior to intervention (Month 0), and post-intervention (Month 6). The investigators will compare changes in fluency scores both pre- and post- in the intervention group, but also compare performance on these measures to the control group.
Time Frame
Month 0 (Prior to administration of cognitive rehabilitation tasks) and Month 6 (after administration of cognitive rehabilitation tasks)
Secondary Outcome Measure Information:
Title
Changes in performance on cognitive rehabilitation tasks (composite measure of memory tasks)
Description
In the intervention group, the investigators will examine speed and accuracy data on all cognitive rehabilitation memory tasks. Tasks will be converted into a single memory composite measure (for both speed and accuracy data). The investigators will cull performance on the tasks on a weekly basis. Weekly data will be treated as a single data points. Participants will be followed for approximately 24 weeks (or 6 months). The investigators will use a regression analysis to analyze to determine changes in the slope on speed and accuracy for each of these data points. Additionally, the investigators will use inferential statistics, such as ANOVA, to determine if participants improve on a week by week basis. These analyses will be conducted on the composite of memory data collected from all the memory tasks.
Time Frame
During intervention (6 month time frame, composite measure)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew E Budson, MD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Effectiveness of Home-based Electronic Cognitive Therapy in Alzheimer's Disease

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