Mild Cognitive Impairment Clinical Trial
Official title:
Evaluation of a Behavioural Intervention for People Living With Mild Cognitive Impairment
Mild cognitive impairment (MCI) is a significant risk factor for dementia. Persons with MCI experience cognitive changes, most typically affecting memory; that are greater than those experienced in "normal" aging. However, these cognitive changes in MCI, unlike in dementia, are not significant enough to markedly interfere with functional independence. In addition to cognitive change, some people with MCI also experience elevated symptoms of depression and anxiety, which adds to their risk of developing dementia. Close family are also impacted by their relative's MCI and show mild physical (e.g., increased incidence of systemic health problems such as high blood pressure) and mental health declines (e.g., elevated symptoms associated with depression and anxiety) that are similar, though not as severe, to those experienced by caregivers of a relative with dementia. Programs aimed at behavioural intervention have real potential to reduce and/or prevent negative health outcomes associated with MCI and future dementia by promoting positive behaviour changes. We wish to scientifically establish the utility of a behavioural intervention aimed at addressing the needs of both the person with MCI and their close family member, with the ultimate goal of lowering current and future susceptibility to mental health declines and chronic disease in people living with MCI. We have an 8 session (16 hour) program, where participants with MCI and their close relative are together for the first half of each session, which is devoted primarily to enabling positive lifestyle choice. In the second hour the group splits up, with MCI clients engaging in memory training while their close family member participates in a psychosocial intervention.
The following outcomes from our multicomponent behavioural intervention are expected.
MCI participants will show:
1) Improved functional memory 2) Increased engagement in leisure activities 2) Improved
instrumental activities of daily living 4) A reduction in neuropsychiatric symptoms (e.g.,
depressed mood, irritability)
Family members of MCI relatives will show:
1. Improvement in ability to adapt to and effectively manage challenges posed from living
with a relative experiencing cognitive decline
2. Improvement in mood
3. Improvement in one or more health related behaviours
These expected outcomes are based on previously presented pilot showing improved abilities
dealing with problems faced from cognitive decline due to MCI, previous research by one of
us demonstrating that self-perceptions of better problem solving skills are associated with
positive intervention outcomes, previous research showing improvement in mood and well-being
in dementia caregivers following psychosocial intervention, and our previous findings of
improved memory knowledge and strategy use in people with MCI after experiencing a similar
intervention.
In researching these expected outcomes we will additionally investigate the following
hypotheses:
1. The degree of cognitive, functional, and neuropsychiatric impairments exhibited by the
MCI clients at baseline will influence the degree of benefit experienced by both the
MCI clients and their family members on the expected outcomes outlined above.
i. In the MCI client degree of impairment may limit the gains achieved because greater
impairment may reduce the ability to self-initiate and sustain behavior change.
ii. Conversely, in the family members, degree of impairment in their MCI relative may
enhance the gains achieved because past research suggests family members whose
relatives with MCI exhibit greater neuropsychiatric symptoms may have the most to gain
from early intervention, as these family members report the most significant depressive
symptoms and more time spent providing support.
2. Based on our past research we expect that level of program participation (e.g.,
attendance, engagement with program materials and exercises) will influence degree of
benefit experienced by both the MCI clients and their family members on the outcome
measures.
METHODS
Participant Identification and Recruitment. Participants for the proposed research will be
consenting individuals with MCI and their close family member, recruited from referrals to
the clinical program. After referrals are received, and before the program begins, the
research assistant will telephone the individuals with MCI and their identified family
members in order to explain the study, to obtain verbal consent, and to gather preliminary
demographic information. To confirm that the potential MCI participants meet accepted
clinical research criteria for amnestic MCI (either single or multiple domain) they will
complete a clinical assessment, including a clinical interview and brief cognitive testing,
3 months prior to the start of their participation in the program. Clinical assessment
results will be reviewed by two clinical neuropsychologists (KM, AT) involved in the initial
development and/or continued provision of the clinical program, who have extensive
experience diagnosing MCI for research purposes. In addition to ensuring that the MCI
participants meet recognized criteria for amnestic MCI, these descriptive data will be used
to investigate our previously mentioned hypotheses examining predictors of effectiveness. To
clarify, family members are only permitted to participate if they have a relative who is
diagnosed with MCI through our clinical triage process (interview plus brief cognitive
assessment). A family member would still be welcome to participate in our program if their
relative with MCI declined to attend or dropped out, although to date this has not yet
happened. Notably, our program is a clinical service, and volunteering for the research
study is not required for participation in the program.
Design. This study will use a randomized waitlist control design. Because of the heavy
demand for this clinical program, there is a naturally-occurring waitlist of approximately 3
months. Thus, three months prior to a new program session, research volunteers from the
program's clinical waitlist will be randomly assigned to a waitlist-control or treatment
group using a random number generator. This random assignment will be conducted after all
volunteers have completed baseline testing. Research shows baseline testing can be
influenced by participant knowledge and expectations and indeed our own pilot testing showed
this influence whereby the treatment group was reported to have poorer functional skills as
compared to the waitlist group in the absence of any other discernible group differences.
Thus, in our design we will attempt to control for the influence of anticipated treatment on
the outcome measures by having both treatment and waitlist-control groups undergo the same
three evaluations at the same time periods: baseline pre-test before random assignment;
repeat testing at 10 weeks (which will serve as the post-test measure for the waitlist
control group and the repeat-pre-test measure for the treatment group) and repeat testing at
20 weeks (which will serve as the post-test measures of the treatment group at 1 month
follow-up and the repeat post-test measure for the waitlist group). The group comparisons
that will allow us to determine the efficacy of the program in comparison to no program will
be through examining the waitlist-control group test schedule 1 versus test schedule 2, and
the treatment group test schedule 2 versus test schedule 3. All individuals, regardless of
their initial group assignment, will be tested before and after their involvement in the
program permitting us to determine individual differences in the degree of benefit obtained
from the program. Although there is a 3-month follow-up session in the current program
format, testing at this time period is not included in the experimental design because there
is no control group for comparison due to program frequency (4 per year) and length of
naturally occurring waitlist (3 months). To determine the effectiveness of the intervention,
we will use a battery that includes both paper-and-pencil questionnaires that are filled out
at home, telephone interviews, and on-site group testing.
Sample size. Sample size estimates for MCI interventions were determined based on our
previous research; for caregiver interventions, these were calculated using effect sizes (g)
from a meta-analysis and Cohen's power tables. For behavioural interventions aimed at MCI,
our previous research showed large and significant behavioural changes (ηp2 = .28 - .33)
with sample sizes of 24 per group. For caregiver interventions most similar in nature to
ours, effect sizes for improvements in a variety of outcome measures ranged from g = .22 to
.52. For comparisons using alpha of .05 and power of .80, we estimate statistically
significant effects with sample sizes of 30 to 46 per population group for the smallest
effects (i.e., on measures of mood) to less than 8 per group for the largest effects (i.e.,
on measures of coping). Given the multiple comparisons, we plan to recruit 60 (30 MCI, 30
family members) for the treatment groups and 60 (30 MCI, 30 family members) for the waitlist
control group. Based on the most recent annual attendance of 111 people for this clinical
program (66 MCI and 45 family), we anticipate no difficulty recruiting this number of
participants over the two year granting period. Based on drop-out rates of 11% in our
previous studies, we will recruit 144 (72 MCI and 72 family members) over the two years in
order to retain 120 (60 MCI and 60 family members) participants for our final sample.
Analyses. Prior to conducting our analyses we will impute missing data in SAS v 9.2 using
multiple imputation methods that assume the missing data will be missing at random (MAR) or
missing completely at random (MCAR). This model-based strategy for missing data provides
significantly better parameter estimates than strategies such as mean substitution or
listwise deletion of missing cases. To test our hypotheses that the intervention will result
in improved leisure engagement, mood, and functional skills in MCI and in improved
health-related behaviours, mood, and adaptive problem solving in family members we will
separately consider the MCI participants and their family members and examine program
effectiveness by comparing treatment and waitlist-control groups at the respective post-test
assessment on each measure using repeated measures analyses of covariance; baseline scores
will be used as covariates in order to reduce between-subject variance and to enhance
detection of between-group differences. We will also perform a qualitative thematic analysis
of responses on our social validity measure to further evaluate the clinical significance of
the intervention and to provide information for further improvements to the intervention. To
test our hypotheses about the influences of the cognitive and behavioural characteristics of
the MCI participants on intervention outcomes [namely that MCI clients with greater
impairments will show the least benefit; however, their family members will show the most
benefit] we will use multiple regression to investigate which factors moderate change in
both the family members' health behaviours, mood, and adaptive skills and in the MCI
participants leisure activity engagement, mood, and functional skills. Specifically, we will
examine the predictive contribution of (i) the MCI client's abilities (degree of
neuropsychiatric symptomatology and level of everyday functioning, obtained from self and
family report, and level of cognitive impairment, obtained from direct assessment of the MCI
client), and (ii) the MCI clients' intervention-related change in memory strategy knowledge
and use (objective and self-report measures obtained directly from the MCI clients) to the
benefits obtained as measured by outcome measure change scores from pre-test to post-test.
Feasibility. The program is offered as a regular clinical service, free of cost to
participants, with four programs offered each year. In the past year, 86 clients with MCI
and 67 of their family members participated. We currently have 13 MCI clients and 12 family
members on the waitlist for our next series beginning in April, with additions to the list
occurring almost daily. Although participation in research is not a requirement for
attendance in this clinical program, we have a high rate of past participant recruitment
from people accessing this intervention program, as demonstrated by previous program
evaluations. The assembled team of clinician researchers has significant clinical expertise
in normal and abnormal cognitive aging, designing and implementing effective cognitive
intervention in normal and neurological populations, and in health outcomes associated with
caregiving and caregiver interventions. Drs. Murphy (lead investigator) and Rowe
(neuropsychologists) and Ms. Climans (social worker) are directly involved in the crafting
and current provision of the program and will execute the research study. Drs. Troyer
(neuropsychologist also involved in crafting of the intervention protocol), MacKenzie
(psychologist), and Dawson (scientist with background in occupational therapy) will provide
ongoing consultation regarding project execution, measurement of outcomes, and analysis and
interpretation of findings based on their relevant areas of expertise.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04513106 -
Promoting Advance Care Planning for Persons With Early-stage Dementia in the Community: a Feasibility Trial
|
N/A | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Recruiting |
NCT04522739 -
Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease
|
Phase 4 | |
Active, not recruiting |
NCT03167840 -
Falls Prevention Through Physical And Cognitive Training in Mild Cognitive Impairment
|
N/A | |
Active, not recruiting |
NCT03676881 -
Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
|
||
Not yet recruiting |
NCT05041790 -
A Clinical Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate Compared to Placebo in Patients With Degenerative Mild Cognitive Impairment
|
Phase 4 | |
Recruiting |
NCT04121156 -
High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Patients With Mild Cognitive Impairment
|
N/A | |
Recruiting |
NCT03605381 -
MORbidity PRevalence Estimate In StrokE
|
||
Completed |
NCT02774083 -
Cognitive Training Using Feuerstein Instrumental Enrichment
|
N/A | |
Completed |
NCT01315639 -
New Biomarker for Alzheimer's Disease Diagnostic
|
N/A | |
Enrolling by invitation |
NCT06023446 -
Can (Optical Coherence Tomography) Pictures of the Retina Detect Alzheimer's Disease at Its Earliest Stages?
|
||
Completed |
NCT04567745 -
Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers
|
Phase 1 | |
Recruiting |
NCT05579236 -
Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
|
||
Completed |
NCT03583879 -
Using Gait Robotics to Improve Symptoms of Parkinson's Disease
|
N/A | |
Terminated |
NCT02503501 -
Intranasal Glulisine in Amnestic Mild Cognitive Impairment and Probable Mild Alzheimer's Disease
|
Phase 2 | |
Not yet recruiting |
NCT03740178 -
Multiple Dose Trial of MK-4334 in Participants With Alzheimer's Clinical Syndrome (MK-4334-005)
|
Phase 1 | |
Active, not recruiting |
NCT05204940 -
Longitudinal Observational Biomarker Study
|
||
Recruiting |
NCT02663531 -
Retinal Neuro-vascular Coupling in Patients With Neurodegenerative Disease
|
N/A | |
Recruiting |
NCT06150352 -
Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
|
||
Recruiting |
NCT03507192 -
Effects of Muscle Relaxation on Cognitive Function in Patients With Mild Cognitive Impairment and Early Stage Dementia.
|
N/A |