Study Stopped
Study was never started due to the Covid 19 pandemic.
STRATEGIES to Improve Memory in Alzheimer's Disease
Improving Memory in Daily Life of Patients With Alzheimer's Disease
2 other identifiers
interventional
N/A
0 countries
N/A
Brief Summary
Memory mistakes are one of the most detrimental symptoms in Alzheimer's Disease (AD). In this study the investigators will measure the long-term efficacy of memory strategies in patients with AD. First, the efficacy of the strategies will be evaluated in the laboratory by analyzing the behavioral response and the brain activity of the patients. During the first visit, patients will be taught the memory strategies and asked to repeat them at home for 4 weeks. During this period of time, patients will perform several memory tasks while their performance and brain activity will be measured using portable devices. Monitoring brain activity and behavioral responses to memory tasks will provide insightful information on the efficacy of the strategies and allow the investigation of how patients can maintain the strategies over time. The research will examine if improving memory through the use of cognitive strategies, can positively affect other domains of daily life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2022
Shorter than P25 for not_applicable alzheimer-disease
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2021
CompletedFirst Posted
Study publicly available on registry
June 28, 2021
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedNovember 1, 2022
October 1, 2022
8 months
June 9, 2021
October 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in performance in memory tasks over time
Change in performance in memory tasks will be measured through daily at home memory exercises that will last from 20 minutes to 1 hour. Higher the scores on the exercise represent better memory performance.
baseline, 4 weeks
Secondary Outcomes (8)
Change in electroencephalogram (EEG) early negative frontal component (N400)
Baseline, 4 weeks
Change in EEG Late Positive Parietal Component (LPC)
Baseline, 4 weeks
Change in EEG Late Positive Frontal Effect (LFE)
Baseline, 4 weeks
Neuropsychological assessment using the Montreal Cognitive Assessment (MoCA)
baseline, 4 weeks
Neuropsychological assessment using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
Baseline, 4 weeks
- +3 more secondary outcomes
Study Arms (2)
Group 1- 15 Mild AD and 15 MCI due to AD
EXPERIMENTALIn Group 1, for the first 2 weeks participants will be taught memory strategies and reminded to use them each day from week 0 to week 2. Weeks 3-4, participants will be advised to keep using the strategies both on the tablet and in their daily life even though they will not be reminded each time they start the task.
Group 2- 15 Mild AD and 15 MCI due to AD
ACTIVE COMPARATORIn Group 2, for the first 2 weeks participants will be reminded to "try hard" to remember the items although they will not be given any specific strategies. At week 2 the subjects will be taught memory strategies and reminded to use them each day from week 2 to week 4.
Interventions
Memory strategies will consist of daily at-home exercises lasting between 20 minutes to 1 hour depending on the memory tasks assigned to each participant. At the start of week 1 participants will be taught the memory strategies to use while completing the daily memory tasks. In week 1 and 2, subjects will be reminded daily to use the memory strategies. At the start of week 3, subjects will be advised to use the memory strategies however they will not be given daily reminders.
A cap that measures brain activity using a 16-sensor wireless dry (no gel applied) EEG device designed by BrainWaveBank Ltd., that uses Bluetooth technology to securely transmit EEG signals to an Android tablet. The cap will be used during week 1,2,3 and 4.
A computer tablet will be provided to each participant that will have daily reminders about the memory strategies during week 1 and 2, while no reminders will be present in week 3 and 4. The tablet software includes a user-friendly interface that provides feedback and instructions that help the participant properly wear the EEG headset. At the end of each session the tablet stores behavioral and EEG data on a secured server accessible by the research staff.
Memory strategies will consist of daily at home exercises lasting between 20 minutes to 1 hour depending on the memory tasks assigned to each participant. During weeks 1 and 2, participants will be completing the memory tasks without being instructed to use any specific strategy. At the end of week 2 subjects will be taught the memory strategies and during week 3 and 4, they will be reminded daily to use the memory strategies while completing the memory tasks.
A cap that measures brain activity using a 16-sensor wireless dry (no gel applied) EEG device designed by BrainWaveBank Ltd., that uses Bluetooth technology to securely transmit EEG signals to an Android tablet. The cap will be used during week 1,2,3 and 4.
A computer tablet will be provided to each participant. During week 3 and 4, the tablet will present daily reminders to use memory strategies while completing the memory tasks. The tablet software includes a user-friendly interface that provides feedback and instructions that help the participant properly wear the EEG headset. At the end of each session the tablet stores behavioral and EEG data on a secured server accessible by the research staff.
Eligibility Criteria
You may qualify if:
- For Mild Alzheimer Disease (AD) dementia
- meets probable AD dementia National Institute on Aging and Alzheimer's Association (NIA-AA) criteria
- Mini-Mental State Examination (MMSE) 20-27
- performance on delayed recall and recognition memory worse than 1.5 standard deviation (SD) for age and education
- performance on delayed recall and recognition memory worse than 1.5 SD for age \& education in at least one other cognitive domain (e.g., language, executive functioning) based on other tests in our neuropsychological test battery.
- Dr. Turk and Dr. Budson will confirm all mild AD dementia diagnoses
- For Mild cognitive impairment (MCI)
- meets MCI due to AD NIA-AA criteria
- MMSE \> 23
- performance on delayed recall and recognition memory worse than 1.0 SD for age \& education adjusted norms
- Dr. Turk and Dr. Budson will confirm all MCI due to AD diagnoses
You may not qualify if:
- A clinically significant problem of any of the following conditions:
- depression
- heavy alcohol or drug use
- cerebrovascular disease
- traumatic brain damage
- a different degenerative disease (e.g., fronto-temporal dementia, Parkinson's disease)
- any medical condition whose severity could significantly impair cognition (e.g., organ failure)
- Unable to understand the consent form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Universitylead
- National Institute on Aging (NIA)collaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katherine Turk, MD
BU School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2021
First Posted
June 28, 2021
Study Start
October 1, 2022
Primary Completion
June 1, 2023
Study Completion
June 1, 2023
Last Updated
November 1, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share