- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04474379
Everyday Memory Impairment in PD-related Cognitive Decline (PMT2)
Prospective Memory Impairment in Parkinson Disease-related Cognitive Decline: Intervention and Mechanisms
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Parkinson disease (PD) causes cognitive deficits that can impair instrumental activities of daily living function and quality of life (QOL) even in the absence of dementia. Currently, there are no treatments to address this pressing burden and, even worse, some medical treatments for PD can exacerbate cognitive deficits. For these reasons, behavioral interventions that attenuate the negative functional consequences of cognitive decline in PD and thus potentially delay the onset of dementia are in high demand. An intervention that enables people with PD to remember to perform necessary and meaningful daily activities could improve or maintain their independence, disease self-management, participation in society, and reduce caregiver burden. The primary goal of this study is to determine the efficacy of such an intervention. Importantly, in doing so, the investigators will directly address a critical point of contention in cognitive intervention research: Which approach (process or strategy training) is the best option for producing functionally-relevant benefits for people with PD? Additionally, the study team will investigate behavioral and neurobiological correlates of prospective memory in PD, including individual characteristics that may predict treatment response. This work will lead to a targeted and tailored biobehavioral intervention that optimizes function, promotes QOL, and improves the long-term management of a common chronic neurological condition. It will move the field of rehabilitation forward by providing valuable theoretical and practical information related to the type of cognitive intervention approach that is most appropriate for people with PD. This then will stimulate and justify the channeling of future research efforts and funding toward further development, testing, dissemination, and implementation of said approach.
Primary Outcomes:
Aim 1. Laboratory prospective memory performance - The Virtual Week test will be administered to PD participants at Pre and Post to assess near transfer of training objectively (primary endpoint). It will also be administered to PD participants at 12mo FU to explore long term training effects (secondary endpoint) and to HC participants at Pre to investigate neural mechanisms of prospective memory performance (Aim 3). It is a computerized board game that simulates daily life and real-world prospective memory challenges. Each circuit represents one day in which the participant completes time-appropriate activities and makes choices about them. Embedded in each day are 8 prospective memory tasks (4 event, 4 time). Participants complete a practice day and then 4 test days; equivalent versions are counterbalanced across testing sessions. The main outcome variable is prospective memory accuracy, defined as the proportion of correct prospective memory responses (32 total: 16 event, 16 time). To further explore the effects of time-based training, the investigators will record strategic clock-checking behavior by requiring participants to click a button to reveal the virtual time of day.
Aim 2. Reported everyday prospective memory: (2a) General everyday prospective memory function - The Prospective and Retrospective Memory Questionnaire (PRMQ)will be administered via web-based or mailed survey to PD participants and informants at Pre, Post and 3mo FU to assess far transfer of training (primary endpoint), to PD participants and informants at 6mo and 12mo FU to explore long term training effects (secondary endpoint), and to HC participants at Pre to determine neural mechanisms of everyday prospective memory (Aim 3). The PRMQ is the most widely used questionnaire for everyday prospective memory. Participants rate the frequency of 8 everyday prospective memory failures (1=Never, 5=Very Often), item scores are summed, and higher scores indicate worse everyday prospective memory. The PRMQ includes environment- and self-cued subscales (4 items each) that parallel the event- and time-based task distinction, respectively. (2b) Personalized real-life prospective memory tasks - The Bangor Goal-Setting Interview (BGSI)offers a standardized means of eliciting individual goals and rating goal attainment over time and has been successfully used in cognitive rehabilitation RCTs with older adults, including those with mild to moderate dementia. During the first two training sessions, after an explanation of the prospective memory task types (session 1: event, session 2: time), participants will complete the BGSI with the trainer to identify and set goals for 3-6 real-life prospective memory tasks they anticipate having to complete over the training period. They and their informants will rate their Pre and Post attainment of these goals on a 10-point scale (1=never remember to do; 10=always remember to do). Goal attainment ratings are averaged to yield mean attainment scores.
Additional measures:
Aims 3 & 4. Neural correlates of prospective memory and treatment response - Rs-fcMRI data will be collected and managed under the auspices of the parent study at Pre. Briefly, MRIs will be completed OFF PD medications on a 3T Siemens Prisma scanner with a 20 channel head coil and include up to 6 BOLD rs-fcMRI scans (416 volumes/run, TE=26.6ms, TR=800ms, FOV= 213mm, flip angle=61°, 3mm3 voxels; multiband factor=4; 5:39min) during fixation (eyes open). More details, including rigorous quality control methods, are in references. The investigators will use a network-level analysis approach using standard nodes from canonical networks. Our primary variables of interest will be intranetwork integrity scores, calculated based on the cross-correlations of each node within the network, for the following cognitive networks: DMN, CON, FPN, PMN, and MTL. Alternate approaches may include seed-based analyses (e.g. DLPFC) and Object Oriented Data Analysis followed by post-hoc identification of significant networks.
Aim 4. Behavioral predictors of treatment response - Based on our pilot RCT (Prelim Data 2)1, The investigators will administer the Credibility and Expectancy Questionnaire (CEQ) and Beck Depression Inventory-II (BDI-II) at Pre as potential motivational predictors of treatment response. The CEQ will be administered at the end of training session 2, so participants have some knowledge of the intervention on which to base their perceptions of credibility and expectancy. The investigators will utilize the extensive neuropsychological data collected at Pre in the parent study to assess potential cognitive predictors of treatment response. Our primary cognitive variables will be the domain z-scores for Memory and Executive Function, computed as the average of standardized scores from measures assessing that domain. Other - PD (and normal cognition for HCs) will be determined via MDS Level II diagnostic criteria in the parent study based on a comprehensive neuropsychological assessment battery and in-depth clinical interviews (CDR). In addition to the main measures of interest described above, the investigators will collect other data to characterize participants, as covariates, or as secondary outcomes (Table 3). This will permit exploration of the influence of sex or other relevant biological variables (e.g. co-morbidities, medication) and broader functional outcomes. The investigators will obtain much of this data from the parent study.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Males and females over age 50 who meet criteria for typical idiopathic PD
- Hoehn & Yahr stage I-III,
- Treated with levodopa/carbidopa
- Have subjective memory complaints (as identified in phone screen),
- Have an informant to complete relevant ratings,
- Medications should be stable for 4 weeks prior with no changes planned during the treatment portion of the study (Pre to Post); changes over the follow-up period will be tracked and accounted for as appropriate.
Exclusion Criteria:
- Dementia according to MDS criteria or MoCA score <21.
- Other neurological disorders (e.g. stroke, seizures), brain surgery, severe systemic diseases, major psychiatric disorder or history of psychotic symptoms (e.g. schizophrenia, bipolar disorder, delusions, hallucinations), or drug abuse.
- Treatment with medications that interfere with cognition (e.g. anticholinergics).
- Any other condition that would interfere with participation (e.g., non-English speaking, significant current depression).
- Psychiatric conditions/ symptoms that are common in PD (e.g. anxiety, depression) are allowed if they are deemed insufficient to interfere with participation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Strategy Training
Consists of 8-90 minute sessions over 8 weeks.
In sessions 1 and 2, in addition to teaching about event- and time-based tasks, the therapist teaches the participant specific strategies for each type of task (implementation intentions for event-based and strategic clock-checking for time-based) and instructs in their use before and during the training games.
In sessions 3-8, the tester tells the participant s/he will be practicing both types of tasks in the training games and can support the participant's strategy use if needed.
Feedback on accuracy and strategy use are provided after each training game.
After completing the training games, the therapist and participant discuss how the strategies can be applied to the participant's real-life prospective memory goals, and the therapist helps the participant develop written action plans to do so.
Plans and goals are reviewed and modified, if necessary, at each session.
|
In time-based training, strategic clock-checking behavior is taught by requiring participants to click a button to reveal the virtual time of day.
Event-based training involves implementation intention methods.
|
No Intervention: Process Training
Consists of 8, 90 minute sessions over 8 weeks.
In sessions 1 and 2, the therapist teaches the participant about event- and time-based prospective memory tasks, respectively.
In sessions 3-8, the tester tells the participant that s/he will be practicing both types of tasks in the training games.
In all sessions, the participant completes the training games with no strategy instruction from the therapist.
Feedback on accuracy is provided after each training game.
This is typical of a process training approach and expects that practice of the training tasks will improve prospective memory ability per se or that participants will develop effective strategies for completing prospective memory tasks on their own.
At the end of each session, the therapist reminds the participant of his/her real-life prospective memory goals, provides a handout that lists the goals, and instructs the participant to try to complete them as intended.
Goals are reviewed and modified if necessary.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Virtual Week Computer-based Memory Test performance after 5-weeks and 12-month post-intervention.
Time Frame: Administered at baseline, pre-treatment session; One week post-treatment (approximately five weeks after the baseline test); and 12-months post-strategy training sessions.
|
A computer-based prospective memory test that simulates a real day where a person has to remember to do tasks.
|
Administered at baseline, pre-treatment session; One week post-treatment (approximately five weeks after the baseline test); and 12-months post-strategy training sessions.
|
Change in The Prospective and Retrospective Memory Questionnaire scores after 5-weeks, 3-months, 6-months, and 12-month post-intervention.
Time Frame: Administered at baseline, pre-treatment session; One week post-treatment (approximately five weeks after the baseline test); then 3-, 6- and 12-months post-completion of strategy training sessions.
|
Participant-reported everyday prospective memory
|
Administered at baseline, pre-treatment session; One week post-treatment (approximately five weeks after the baseline test); then 3-, 6- and 12-months post-completion of strategy training sessions.
|
Change in Bangor Goal Setting Interview goal attainment after 5-weeks and 12-month post-intervention.
Time Frame: Administered at baseline, pre-treatment session; One week post-treatment (approximately five weeks after the baseline test); and 12-months post-strategy training sessions.
|
A standardized measure that elicits individual goals and rating goal attainment over time
|
Administered at baseline, pre-treatment session; One week post-treatment (approximately five weeks after the baseline test); and 12-months post-strategy training sessions.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Erin Foster, PhD, OTD, Washington University School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202007054
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinson Disease
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedParkinson Disease 6, Early-Onset | Parkinson Disease (Autosomal Recessive, Early Onset) 7, Human | Parkinson Disease Autosomal Recessive, Early Onset | Parkinson Disease, Autosomal Recessive Early-Onset, Digenic, Pink1/Dj1United States
-
ProgenaBiomeRecruitingParkinson Disease | Parkinsons Disease With Dementia | Parkinson-Dementia Syndrome | Parkinson Disease 2 | Parkinson Disease 3 | Parkinson Disease 4United States
-
King's College LondonGlaxoSmithKlineCompletedParkinson Disease | Idiopathic Parkinson Disease | Parkinson Disease, PARK8United Kingdom
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
National Yang Ming UniversityUnknownEarly Onset Parkinson Disease | Early Stage Parkinson Disease
-
Michele Tagliati, MDRecruitingREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Cedars-Sinai Medical CenterEnrolling by invitationREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Mahatma Gandhi Institute of Medical SciencesCompletedStroke, Parkinson' s Disease, Neurological Impairments, Tele-rehabilitationIndia
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
University of DeustoCompletedPARKINSON DISEASE (Disorder)Spain
Clinical Trials on Strategy Training (Time- and Event- Based)
-
The University of Texas at DallasCompleted
-
Valleywise HealthCompleted
-
Columbia UniversityNational Institute on Aging (NIA)RecruitingHealthy AgingUnited States
-
St. Justine's HospitalCHU de Quebec-Universite Laval; Université de Sherbrooke; Jewish General Hospital and other collaboratorsCompletedIntubation | Education | Simulation TrainingCanada
-
Peking University People's HospitalTibet Autonomous Region People's HospitalCompletedIntubation Time | Simulation Training | Flexible BronchoscopyChina
-
Seoul National University HospitalRecruitingCardiopulmonary Resuscitation | EducationKorea, Republic of
-
Kessler FoundationRecruitingMultiple SclerosisUnited States
-
YuanYuan MaRecruiting
-
University of PittsburghNational Institute of Mental Health (NIMH)Recruiting
-
University of North Carolina, Chapel HillUnited States Agency for International Development (USAID)CompletedCervical CancerMalawi