STRATEGIES to Improve Memory in Alzheimer's Disease

NCT ID: NCT04942184

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-31
• Study Completion Date: 2023-06-30

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.

Detailed Description

A crossover design with two groups will be implemented to test the following objectives:

Primary Objective: To determine the long-term efficacy of memory strategies in AD patients using experimental memory paradigms and standard neuropsychological tests. Over the course of 4 weeks, performance on novel memory tasks and standard neuropsychological tests will evaluate the efficacy of the strategies longitudinally.

Secondary Objectives:

1. To determine the neural mechanism of memory strategies in AD patients through portable electroencephalogram/event-related potential (EEG/ERP) electrophysiology. Portable EEG will allow us to measure the electrophysiological changes associated with the use of memory strategies over time during daily life of patients with AD.

2. To determine how memory strategies, influence the daily life and functioning of the AD patients. Questionnaires on daily life activities will be administered at different timepoints to determine whether patients are able to generalize the strategies to tasks in their daily life.

This research study will investigate whether the use of combined memory strategies (conservative and deep/item-specific encoding) can help improve performance in memory tasks, can be maintained over time, and can be generalized to other tasks in daily life. Depending on the study group, either at week 0 visit or week 2 visit, participants will be trained on the two strategies. A power point presentation will be used to display one example of each of the strategies and how to implement them during the tablet/Ipad tasks. At this time the investigators will answer any other specific questions that might come up about the strategies. Before starting the cognitive tasks at home on the app, the tablet will remind participants about using the strategies, and this will also include an example how the strategies should be implemented.

The two memory strategies will be implemented in the described steps below:

While being presented with a list of items (words or objects), participants will be asked to focus on one unique characteristic of the items (item-specific encoding strategy). Afterwards, another list of items, containing previously studied (old) and unstudied (new) items, will be presented. Participants will be asked to recognize whether the item was presented in the previous list and respond "yes" only if they are absolutely sure of their response (conservative strategy). Participants will then be provided with a number of real-world examples to practice generalizing what they have learned.

Conditions

Alzheimer Disease; Dementia, Mild; Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 1- 15 Mild AD and 15 MCI due to AD

In 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 Type: EXPERIMENTAL

Memory strategies in Arm 1

Intervention Type: BEHAVIORAL

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.

Electroencephalogram (EEG) headset in Arm 1

Intervention Type: DEVICE

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.

Tablet in Arm 1

Intervention Type: OTHER

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.

Group 2- 15 Mild AD and 15 MCI due to AD

In 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.

Group Type: ACTIVE_COMPARATOR

Memory strategies in Arm 2

Intervention Type: BEHAVIORAL

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.

Electroencephalogram (EEG) headset in Arm 2

Intervention Type: DEVICE

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.

Tablet in Arm 2

Intervention Type: OTHER

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.

Interventions

Memory strategies in Arm 1

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.

Intervention Type: BEHAVIORAL

Electroencephalogram (EEG) headset in Arm 1

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.

Intervention Type: DEVICE

Tablet in Arm 1

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.

Intervention Type: OTHER

Memory strategies in Arm 2

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.

Intervention Type: BEHAVIORAL

Electroencephalogram (EEG) headset in Arm 2

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.

Intervention Type: DEVICE

Tablet in Arm 2

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katherine Turk, MD

Role: PRINCIPAL_INVESTIGATOR

BU School of Medicine

Other Identifiers

P30AG013846

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-40597

Identifier Type: -

Identifier Source: org_study_id