Effectiveness of Home-based Electronic Cognitive Therapy in Alzheimer's Disease
NCT ID: NCT02521558
Last Updated: 2021-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
30 participants
INTERVENTIONAL
2015-09-30
2020-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
90 Years
FEMALE
No
Sponsors
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Wallace H. Coulter Foundation
OTHER
Boston University
OTHER
Responsible Party
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Principal Investigators
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Andrew E Budson, MD
Role: PRINCIPAL_INVESTIGATOR
Boston University
Locations
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Boston University School of Medicine
Boston, Massachusetts, United States
Countries
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References
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Yu F, Rose KM, Burgener SC, Cunningham C, Buettner LL, Beattie E, Bossen AL, Buckwalter KC, Fick DM, Fitzsimmons S, Kolanowski A, Janet K, Specht P, Richeson NE, Testad I, McKenzie SE. Cognitive training for early-stage Alzheimer's disease and dementia. J Gerontol Nurs. 2009 Mar;35(3):23-9. doi: 10.3928/00989134-20090301-10.
Talassi E, Guerreschi M, Feriani M, Fedi V, Bianchetti A, Trabucchi M. Effectiveness of a cognitive rehabilitation program in mild dementia (MD) and mild cognitive impairment (MCI): a case control study. Arch Gerontol Geriatr. 2007;44 Suppl 1:391-9. doi: 10.1016/j.archger.2007.01.055.
Olazaran J, Muniz R, Reisberg B, Pena-Casanova J, del Ser T, Cruz-Jentoft AJ, Serrano P, Navarro E, Garcia de la Rocha ML, Frank A, Galiano M, Fernandez-Bullido Y, Serra JA, Gonzalez-Salvador MT, Sevilla C. Benefits of cognitive-motor intervention in MCI and mild to moderate Alzheimer disease. Neurology. 2004 Dec 28;63(12):2348-53. doi: 10.1212/01.wnl.0000147478.03911.28.
Spector A, Orrell M, Woods B. Cognitive Stimulation Therapy (CST): effects on different areas of cognitive function for people with dementia. Int J Geriatr Psychiatry. 2010 Dec;25(12):1253-8. doi: 10.1002/gps.2464.
Spector A, Thorgrimsen L, Woods B, Royan L, Davies S, Butterworth M, Orrell M. Efficacy of an evidence-based cognitive stimulation therapy programme for people with dementia: randomised controlled trial. Br J Psychiatry. 2003 Sep;183:248-54. doi: 10.1192/bjp.183.3.248.
Burgener SC, Buettner LL, Beattie E, Rose KM. Effectiveness of community-based, nonpharmacological interventions for early-stage dementia: conclusions and recommendations. J Gerontol Nurs. 2009 Mar;35(3):50-7; quiz 58-9. doi: 10.3928/00989134-20090301-03.
Requena C, Lopez Ibor MI, Maestu F, Campo P, Lopez Ibor JJ, Ortiz T. Effects of cholinergic drugs and cognitive training on dementia. Dement Geriatr Cogn Disord. 2004;18(1):50-4. doi: 10.1159/000077735. Epub 2004 Apr 6.
Requena C, Maestu F, Campo P, Fernandez A, Ortiz T. Effects of cholinergic drugs and cognitive training on dementia: 2-year follow-up. Dement Geriatr Cogn Disord. 2006;22(4):339-45. doi: 10.1159/000095600. Epub 2006 Sep 4.
Finn M, McDonald S. A single case study of computerised cognitive training for older persons with mild cognitive impairment. NeuroRehabilitation. 2014 Jan 1;35(2):261-70. doi: 10.3233/NRE-141121.
Sitzer DI, Twamley EW, Jeste DV. Cognitive training in Alzheimer's disease: a meta-analysis of the literature. Acta Psychiatr Scand. 2006 Aug;114(2):75-90. doi: 10.1111/j.1600-0447.2006.00789.x.
Des Roches CA, Balachandran I, Ascenso EM, Tripodis Y, Kiran S. Effectiveness of an impairment-based individualized rehabilitation program using an iPad-based software platform. Front Hum Neurosci. 2015 Jan 5;8:1015. doi: 10.3389/fnhum.2014.01015. eCollection 2014.
Marin A, DeCaro R, Schiloski K, Elshaar A, Dwyer B, Vives-Rodriguez A, Palumbo R, Turk K, Budson A. Home-Based Electronic Cognitive Therapy in Patients With Alzheimer Disease: Feasibility Randomized Controlled Trial. JMIR Form Res. 2022 Sep 12;6(9):e34450. doi: 10.2196/34450.
Other Identifiers
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H-34203
Identifier Type: -
Identifier Source: org_study_id
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