Clinical trial NCT04942184: STRATEGIES to Improve Memory in Alzheimer's Disease
Official title: Improving Memory in Daily Life of Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Alzheimer Disease
Dementia, Mild
Mild Cognitive Impairment
Keywords: Memory
Memory Strategies
EEG headgear
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-06-28
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in performance in memory tasks over time
timeFrame: baseline, 4 weeks
Secondary outcomes:
measure: Change in electroencephalogram (EEG) early negative frontal component (N400)
timeFrame: Baseline, 4 weeks
measure: Change in EEG Late Positive Parietal Component (LPC)
timeFrame: Baseline, 4 weeks
measure: Change in EEG Late Positive Frontal Effect (LFE)
timeFrame: Baseline, 4 weeks
measure: Neuropsychological assessment using the Montreal Cognitive Assessment (MoCA)
timeFrame: baseline, 4 weeks
measure: Neuropsychological assessment using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
timeFrame: Baseline, 4 weeks
measure: Generalization of strategies to daily life functioning
timeFrame: Baseline, 4 weeks
measure: Quality of life with Alzheimer's disease
timeFrame: Baseline, 4 weeks
measure: Subjective perception of memory performance
timeFrame: Baseline, 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: BU School of Medicine
name: Katherine Turk, MD
role: PRINCIPAL_INVESTIGATOR
References: