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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02521558
Recruitment Status : Suspended (Currently suspended due to COVID-19 policies.)
First Posted : August 13, 2015
Last Update Posted : April 21, 2020
Sponsor:
Collaborator:
Wallace H. Coulter Foundation
Information provided by (Responsible Party):
Boston University

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.

Condition or disease Intervention/treatment Phase
Memory Disorders Mild Cognitive Impairment Alzheimer's Disease Behavioral: Intervention Group Behavioral: Control Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Home-based Electronic Cognitive Therapy in Alzheimer's Disease
Actual Study Start Date : September 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Intervention Group
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.
Behavioral: Intervention Group
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.

Active Comparator: Control Group
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.
Behavioral: Control Group

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 Measures :
  1. Changes in cognition as measured by the Mini Mental Status Exam [ Time Frame: Month 0 (Prior to administration of cognitive rehabilitation tasks) and Month 6 (after administration of cognitive rehabilitation tasks) ]

    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.


  2. Changes in cognition as measured by the Montreal Cognitive Assessment [ Time Frame: Month 0 (Prior to administration of cognitive rehabilitation tasks) and Month 6 (after administration of cognitive rehabilitation tasks) ]

    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.


  3. Changes in cognition as measured by the Consortium to Establish a Registry in Alzheimer's disease Word List Test [ Time Frame: Month 0 (Prior to administration of cognitive rehabilitation tasks) and Month 6 (after administration of cognitive rehabilitation tasks) ]

    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.


  4. Changes in cognition as measured Letter and Category Fluency [ Time Frame: Month 0 (Prior to administration of cognitive rehabilitation tasks) and Month 6 (after administration of cognitive rehabilitation tasks) ]

    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.


  5. Changes in cognition as measured by the Boston Naming Test (Short Form) [ Time Frame: Month 0 (Prior to administration of cognitive rehabilitation tasks) and Month 6 (after administration of cognitive rehabilitation tasks) ]

    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.


  6. Changes in cognition as measured by the Trail Making Parts A & B [ Time Frame: Month 0 (Prior to administration of cognitive rehabilitation tasks) and Month 6 (after administration of cognitive rehabilitation tasks) ]

    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 :
  1. Changes in performance on cognitive rehabilitation tasks (composite measure of memory tasks) [ Time Frame: During intervention (6 month time frame, composite measure) ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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): NCT02521558


Locations
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United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Boston University
Wallace H. Coulter Foundation
Investigators
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Principal Investigator: Andrew E Budson, MD Boston University
Publications:

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Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT02521558    
Other Study ID Numbers: H-34203
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston University:
Cognitive rehabilitation
Mobile electronic application
Memory tasks
Additional relevant MeSH terms:
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Alzheimer Disease
Memory Disorders
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms