Alzheimer DiseaseNCT04942184
STRATEGIES to Improve Memory in Alzheimer's Disease
A study testing Memory strategies in Arm 1, Electroencephalogram (EEG) headset in Arm 1 and Tablet in Arm 1 in people with Alzheimer Disease and Dementia, Mild, run by Boston University.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer Disease, Dementia, Mild, Mild Cognitive Impairment
- What is being tested?
- Memory strategies in Arm 1, Electroencephalogram (EEG) headset in Arm 1 and Tablet in Arm 1
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
About this study
Official title: Improving Memory in Daily Life of Patients With Alzheimer's Disease
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.
Read the 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:
- 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.
- 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
- Being tested
- Memory strategies in Arm 1, Electroencephalogram (EEG) headset in Arm 1, Tablet in Arm 1, Memory strategies in Arm 2, Electroencephalogram (EEG) headset in Arm 2
- Keywords
- Memory, Memory Strategies, EEG headgear
- Medical subject headings
- Alzheimer Disease, Dementia, Lymphoma, Follicular, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memory strategies in Arm 1Behavioural
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 1Device
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 1Other
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 in Arm 2Behavioural
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 2Device
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 2Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1- 15 Mild AD and 15 MCI due to AD | Experimental | 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. Receives: Behavioral: Memory strategies in Arm 1; Device: Electroencephalogram (EEG) headset in Arm 1; Other: Tablet in Arm 1 |
| Group 2- 15 Mild AD and 15 MCI due to AD | Active comparator | 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. Receives: Behavioral: Memory strategies in Arm 2; Device: Electroencephalogram (EEG) headset in Arm 2; Other: Tablet in Arm 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 4 weeks
Secondary outcomes (8)
Change in electroencephalogram (EEG) early negative frontal component (N400)
Change in EEG early negative frontal component (N400) will be assessed by measuring amplitude and latency characteristics of this EEG component. A higher amplitude and shorter latency will show improvement in memory performance.
Measured: Baseline, 4 weeks
Change in EEG Late Positive Parietal Component (LPC)
Change in EEG Late Positive Parietal Component (LPC) will be assessed by measuring amplitude and latency characteristics of this EEG component. A higher amplitude and shorter latency will show improvement in memory performance.
Measured: Baseline, 4 weeks
Change in EEG Late Positive Frontal Effect (LFE)
Change in EEG Late Positive Frontal Effect (LFE) will be assessed by measuring the amplitude and latency characteristics of this EEG component. A higher amplitude and shorter latency will show improvement in memory performance.
Measured: Baseline, 4 weeks
Neuropsychological assessment using the Montreal Cognitive Assessment (MoCA)
Neuropsychological assessment will be completed using the Montreal Cognitive Assessment (MoCA).
The MoCA has a total score of 30, and a higher score means improved cognitive performance.
Measured: baseline, 4 weeks
Neuropsychological assessment using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
Neuropsychological assessment will be completed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). The RBANS has a total index score of 160, and it measures performance in the following domains: immediate memory, visuospatial, language, attention, and delayed memory. A higher score on the RBANS means improved cognitive performance.
Measured: Baseline, 4 weeks
Generalization of strategies to daily life functioning
Generalization of strategies will be assessed through the Activities of Daily Living Scale (ADL) which is a 31-item questionnaire assessing the ability to complete activities of daily living. The minimum score is 0 while the maximum score is 279. A lower score on the Activities of Daily life scale means a greater level of independence in completing activities of daily life.
Measured: Baseline, 4 weeks
Quality of life with Alzheimer's disease
Quality of life will be assessed with the Quality of Life in Alzheimer's Disease (QoLAD) which is a 13-item questionnaire assessing different aspects of quality of life. The minimum score is 13 and the maximum is 52. A higher score represents better quality of life.
Measured: Baseline, 4 weeks
Subjective perception of memory performance
Subjective perception of memory performance will be assessed using the Multifactorial Metamemory Questionnaire (MMQ), which is a 61-item questionnaire divided in three subcategories (Contentment, Ability and Strategy). The minimum score is 0 and the maximum is 244. A higher score means a better subjective memory performance.
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study startOct 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Why it stopped: Study was never started due to the Covid 19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Katherine Turk, MD, Principal investigator, BU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942184
- Sponsor's protocol ID
- H-40597
- Other IDs
- P30AG013846
- Status last verified
- Oct 2022
- First submitted
- 9 Jun 2021
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Memory in Daily Life of Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04942184
- Acronym / sponsor ID
- H-40597
- Conditions
- Alzheimer Disease, Dementia, Mild, Mild Cognitive Impairment
- Keywords
- Memory, Memory Strategies, EEG headgear
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never started due to the Covid 19 pandemic.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Oct 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 28 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1- 15 Mild AD and 15 MCI due to AD | Experimental | Behavioral: Memory strategies in Arm 1, Device: Electroencephalogram (EEG) headset in Arm 1, Other: Tablet in Arm 1In 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 comparator | Behavioral: Memory strategies in Arm 2, Device: Electroencephalogram (EEG) headset in Arm 2, Other: Tablet in Arm 2In 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. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (8 listed)
- depression
- heavy alcohol or drug use
- cerebrovascular disease
- traumatic brain damage
- a different degenerative disease (e.g., fronto-temporal dementia, Parkinson's disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Memory strategies in Arm 1Memory 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. | Behavioural | Group 1- 15 Mild AD and 15 MCI due to AD |
| Electroencephalogram (EEG) headset in Arm 1A 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. | Device | Group 1- 15 Mild AD and 15 MCI due to AD |
| Tablet in Arm 1A 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. | Other | Group 1- 15 Mild AD and 15 MCI due to AD |
| Memory strategies in Arm 2Memory 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. | Behavioural | Group 2- 15 Mild AD and 15 MCI due to AD |
| Electroencephalogram (EEG) headset in Arm 2A 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. | Device | Group 2- 15 Mild AD and 15 MCI due to AD |
| Tablet in Arm 2A 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. | Other | Group 2- 15 Mild AD and 15 MCI due to AD |
Primary outcome
Change in performance in memory tasks over time
Time frame: baseline, 4 weeks
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.
8 secondary outcomes
Change in electroencephalogram (EEG) early negative frontal component (N400)
Time frame: Baseline, 4 weeks
Change in EEG Late Positive Parietal Component (LPC)
Time frame: Baseline, 4 weeks
Change in EEG Late Positive Frontal Effect (LFE)
Time frame: Baseline, 4 weeks
Neuropsychological assessment using the Montreal Cognitive Assessment (MoCA)
Time frame: baseline, 4 weeks
Neuropsychological assessment using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
Time frame: Baseline, 4 weeks
Generalization of strategies to daily life functioning
Time frame: Baseline, 4 weeks
Quality of life with Alzheimer's disease
Time frame: Baseline, 4 weeks
Subjective perception of memory performance
Time frame: Baseline, 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Turk, MD principal investigator
BU School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Memory strategies in Arm 1, Electroencephalogram (EEG) headset in Arm 1 and Tablet in Arm 1 in people with Alzheimer Disease and Dementia, Mild, run by Boston University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in performance in memory tasks over time (time frame: baseline, 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.