Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02521558
Other study ID # H-34203
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date June 30, 2020

Study information

Verified date February 2021
Source Boston University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 30
Est. completion date June 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers No
Gender Female
Age group 50 Years to 90 Years
Eligibility 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.

Study Design


Intervention

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.
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.

Locations

Country Name City State
United States Boston University School of Medicine Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Boston University Wallace H. Coulter Foundation

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. Review. — View Citation

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. — View Citation

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. — View Citation

Olazarán J, Muñiz R, Reisberg B, Peña-Casanova J, del Ser T, Cruz-Jentoft AJ, Serrano P, Navarro E, García de la Rocha ML, Frank A, Galiano M, Fernández-Bullido Y, Serra JA, González-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. — View Citation

Requena C, López Ibor MI, Maestú F, Campo P, López Ibor JJ, Ortiz T. Effects of cholinergic drugs and cognitive training on dementia. Dement Geriatr Cogn Disord. 2004;18(1):50-4. Epub 2004 Apr 6. — View Citation

Requena C, Maestú F, Campo P, Fernández 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. Epub 2006 Sep 4. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Month 0 (Prior to administration of cognitive rehabilitation tasks) and Month 6 (after administration of cognitive rehabilitation tasks)
Primary 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.
Month 0 (Prior to administration of cognitive rehabilitation tasks) and Month 6 (after administration of cognitive rehabilitation tasks)
Primary 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.
Month 0 (Prior to administration of cognitive rehabilitation tasks) and Month 6 (after administration of cognitive rehabilitation tasks)
Primary 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.
Month 0 (Prior to administration of cognitive rehabilitation tasks) and Month 6 (after administration of cognitive rehabilitation tasks)
Primary 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.
Month 0 (Prior to administration of cognitive rehabilitation tasks) and Month 6 (after administration of cognitive rehabilitation tasks)
Primary 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.
Month 0 (Prior to administration of cognitive rehabilitation tasks) and Month 6 (after administration of cognitive rehabilitation tasks)
Secondary 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.
During intervention (6 month time frame, composite measure)
See also
  Status Clinical Trial Phase
Completed NCT04513106 - Promoting Advance Care Planning for Persons With Early-stage Dementia in the Community: a Feasibility Trial N/A
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Recruiting NCT04522739 - Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease Phase 4
Active, not recruiting NCT03167840 - Falls Prevention Through Physical And Cognitive Training in Mild Cognitive Impairment N/A
Active, not recruiting NCT03676881 - Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
Not yet recruiting NCT05041790 - A Clinical Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate Compared to Placebo in Patients With Degenerative Mild Cognitive Impairment Phase 4
Recruiting NCT04121156 - High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Patients With Mild Cognitive Impairment N/A
Recruiting NCT03605381 - MORbidity PRevalence Estimate In StrokE
Completed NCT02774083 - Cognitive Training Using Feuerstein Instrumental Enrichment N/A
Completed NCT01315639 - New Biomarker for Alzheimer's Disease Diagnostic N/A
Enrolling by invitation NCT06023446 - Can (Optical Coherence Tomography) Pictures of the Retina Detect Alzheimer's Disease at Its Earliest Stages?
Completed NCT04567745 - Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers Phase 1
Recruiting NCT05579236 - Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
Completed NCT03583879 - Using Gait Robotics to Improve Symptoms of Parkinson's Disease N/A
Terminated NCT02503501 - Intranasal Glulisine in Amnestic Mild Cognitive Impairment and Probable Mild Alzheimer's Disease Phase 2
Not yet recruiting NCT03740178 - Multiple Dose Trial of MK-4334 in Participants With Alzheimer's Clinical Syndrome (MK-4334-005) Phase 1
Active, not recruiting NCT05204940 - Longitudinal Observational Biomarker Study
Recruiting NCT02663531 - Retinal Neuro-vascular Coupling in Patients With Neurodegenerative Disease N/A
Recruiting NCT06150352 - Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
Recruiting NCT03507192 - Effects of Muscle Relaxation on Cognitive Function in Patients With Mild Cognitive Impairment and Early Stage Dementia. N/A