The 5-Cog paradigm to improve detection of cognitive impairment and dementia: clinical trial protocol.
Ontology highlight
ABSTRACT:
SUBMITTER: Chalmer R
PROVIDER: S-EPMC9245592 | biostudies-literature | 2022 Aug
REPOSITORIES: biostudies-literature
Publications
The 5-Cog paradigm to improve detection of cognitive impairment and dementia: clinical trial protocol.
Chalmer Rachel R Ayers Emmeline E Weiss Erica F EF Malik Rubina R Ehrlich Amy A Wang Cuiling C Zwerling Jessica J Ansari Asif A Possin Katherine L KL Verghese Joe J
Neurodegenerative disease management 20220523 4
Cognitive impairment related to dementia is under-diagnosed in primary care despite availability of numerous cognitive assessment tools; under-diagnosis is more prevalent for members of racial and ethnic minority groups. Clinical decision-support systems may improve rates of primary care providers responding to positive cognitive assessments with appropriate follow-up. The 5-Cog study is a randomized controlled trial in 1200 predominantly Black and Hispanic older adults from an urban underserved ...[more]
Similar Datasets
Project description:BackgroundVascular cognitive impairment, no dementia (VCIND) refers to cognitive deficits associated with underlying vascular causes that fall short of a dementia diagnosis. There is currently no treatment for VCIND. Computerized cognitive training, which has significantly improved cognitive function in healthy older adults and patients with cognitive impairment has not yet been applied to VCIND.Methods/designThe proposed study is a three-center, double-blinded, randomized controlled trial that will include 60 patients with VCIND. The patients will be randomized to either a training or a control group. The intervention is internet-based cognitive training performed for 30 min over 35 sessions. Neuropsychological assessment and functional and structural MRI will be performed before and after 7 weeks training. Primary outcomes are global cognitive function and executive function. Secondary outcome measures are neuroplasticity changes measured by functional and structural MRI.DiscussionApplying an internet-based, multi-domain, adaptive program, this study aims to assess whether cognitive training improves cognitive abilities and neural plasticity in patients with subcortical VCIND. In addition to the comprehensive assessment of the participants by neuropsychological tests, cerebrovascular risk factors and apolipoprotein E genotyping, neuroplasticity will be used as an evaluation outcome in this study for, to our knowledge, the first time. The combination of functional and structural MRI and neuropsychological tests will have strong sensitivity in evaluating the effects of cognitive training and will also reveal the underlying mechanisms at work.Trial registrationClinicalTrials.gov NCT02640716 . Retrospectively registered on 21 December 2015.
| S-EPMC4974771 | biostudies-literature
Project description:IntroductionMild cognitive impairment (MCI) is common in older adults and represents a high-risk group for progression to Alzheimer's disease (AD). Medication trials in MCI have generally failed, but new discoveries with brain plasticity in ageing have led to the study of cognitive training as a potential treatment to improve cognitive abilities. Computerised cognitive training (CCT) involves computerised cognitive exercises that target specific cognitive abilities and neural networks to potentially improve cognitive functioning through neuroplasticity.Methods and analysisIn a two-site study (New York State Psychiatric Institute/Columbia University Medical Center and Duke University Medical Center), we will randomise 100 patients with MCI (Wechsler Memory Scale-III Logical Memory II score 0-11; Folstein Mini Mental State Examination ≥23) to home-based CCT (suite of exercises: memory, matching, spatial recognition, processing speed) or a home-based active control condition (computerised crossword puzzle training (CPT)) with 12 weeks of intensive training followed by regular booster sessions up to 78 weeks. All patients will receive standard neuropsychological and functional assessments in clinic as well as structural/functional brain MRI scans at study entry and endpoint. We will test if CCT, versus CPT, leads to improved cognitive functioning, transfers to functional ability and tasks of everyday life and impacts hippocampal volume changes and changes in the default mode network of the brain measured by resting-state functional MRI.Ethics and disseminationThe study will be conducted following ethics approval and written informed consent will be obtained from all subjects. Study results will be disseminated via publication, clinicaltrials.gov, media and conference presentations. This will be the first controlled long-term trial to evaluate the effects of home-based CCT versus computerised CPT on cognitive abilities and functional measures and neural outcomes as determined by MRI indices in patients with MCI. Positive results from trial may support further development of home-based CCT.Trial registration numberClinicalTrials.gov identifier (NCT03205709).
| S-EPMC6720324 | biostudies-literature
Project description:BackgroundClinical endpoints for upcoming therapeutic trials in frontotemporal dementia (FTD) are increasingly urgent. Cognitive composite scores are often used as endpoints but are lacking in genetic FTD. We aimed to create cognitive composite scores for genetic frontotemporal dementia (FTD) as well as recommendations for recruitment and duration in clinical trial design.MethodsA standardized neuropsychological test battery covering six cognitive domains was completed by 69 C9orf72, 41 GRN, and 28 MAPT mutation carriers with CDR® plus NACC-FTLD ≥ 0.5 and 275 controls. Logistic regression was used to identify the combination of tests that distinguished best between each mutation carrier group and controls. The composite scores were calculated from the weighted averages of test scores in the models based on the regression coefficients. Sample size estimates were calculated for individual cognitive tests and composites in a theoretical trial aimed at preventing progression from a prodromal stage (CDR® plus NACC-FTLD 0.5) to a fully symptomatic stage (CDR® plus NACC-FTLD ≥ 1). Time-to-event analysis was performed to determine how quickly mutation carriers progressed from CDR® plus NACC-FTLD = 0.5 to ≥ 1 (and therefore how long a trial would need to be).ResultsThe results from the logistic regression analyses resulted in different composite scores for each mutation carrier group (i.e. C9orf72, GRN, and MAPT). The estimated sample size to detect a treatment effect was lower for composite scores than for most individual tests. A Kaplan-Meier curve showed that after 3 years, ~ 50% of individuals had converted from CDR® plus NACC-FTLD 0.5 to ≥ 1, which means that the estimated effect size needs to be halved in sample size calculations as only half of the mutation carriers would be expected to progress from CDR® plus NACC FTLD 0.5 to ≥ 1 without treatment over that time period.DiscussionWe created gene-specific cognitive composite scores for C9orf72, GRN, and MAPT mutation carriers, which resulted in substantially lower estimated sample sizes to detect a treatment effect than the individual cognitive tests. The GENFI-Cog composites have potential as cognitive endpoints for upcoming clinical trials. The results from this study provide recommendations for estimating sample size and trial duration.
| S-EPMC8772227 | biostudies-literature
Project description:BackgroundHearing and vision impairments are highly prevalent in people with dementia and may have a negative impact on quality of life and other dementia-related outcomes. Intervening to optimise sensory impairment and support sensory function may be a means of improving dementia-related outcomes. The SENSE-Cog trial will test whether a home-based multi-part sensory intervention is effective in improving quality of life and other key outcomes in people with dementia and hearing or vision problems (or both) and their companions.MethodsThis is an European, multi-centre, observer-blind, pragmatic, randomised controlled trial. Three hundred fifty four people with dementia and hearing or vision impairment (or both) and their companions will be randomly assigned to receive either "care as usual" or a multi-component sensory intervention including assessment and correction of hearing or vision impairments (or both), home-based (maximum 10 visits over 18 weeks), therapist-delivered sensory support (that is, adherence to devices; improving the sensory environment (that is, lighting), communication training, and sign-posting to other support agencies). Change from baseline to intervention end (18 weeks) and post-intervention (36 weeks) will be compared between the two arms in the following outcomes: quality of life (primary endpoint), sensory and cognitive functional ability, relationships, mental well-being, health resource utilisation and cost-effectiveness.DiscussionThis is one of two articles outlining the SENSE-Cog trial. Here, we describe the protocol for the effectiveness of the SENSE-Cog intervention. A parallel and complementary process evaluation will be described elsewhere. If the SENSE-Cog trial demonstrates that the sensory intervention improves outcomes in dementia, we will make a toolkit of training materials, resources and information available to health and social care providers to implement the intervention in routine practice. This will be a significant contribution to the therapeutic management of people with dementia and sensory impairment.Trial registrationISRCTN (Trial ID: ISRCTN17056211 ) on 19 February 2018.
| S-EPMC6347775 | biostudies-literature
Project description:Vascular cognitive impairment no dementia (VCIND) is likely to develop into vascular dementia (VD) without intervention. The clinical efficacy of electroacupuncture (EA) for VCIND has been previously demonstrated. However, the neuroimaging mechanism of EA for VCIND has not been elucidated clearly. This trial is designed to provide solid evidence for the efficacy and neuroimaging mechanism of EA treatment for patients with VCIND. This ongoing study is an assessor-blind, parallel-group, randomized controlled trial. 140 eligible subjects will be recruited from the General Hospital of Ningxia Medical University and randomized into either the electroacupuncture (EA) group or the control group (CG). All subjects will receive basic treatment, and participants in the CG will receive health education performed weekly. Except for basic treatment and health education, participants in the EA group will receive treatment 5 times per week for a total of 40 sessions over 8 weeks. The primary outcome in this study is Montreal Cognitive Assessment (MoCA), and the secondary outcomes are Auditory Verbal Learning Test (AVLT), Stroop color-naming condition (STROOP), Rey-Osterrieth Complex Graphics Testing, and resting-state functional magnetic resonance imaging (rs-fMRI). All of the outcome measures will be assessed at baseline and 8 weeks of intervention. The medical abstraction of adverse events will be done at each visit. The results of this trial will demonstrate the efficacy and neuroimaging mechanism of EA treatment for VCIND, thus supporting EA treatment as an ideal choice for VCIND treatment. The trial was registered at the Chinese Clinical Trial Registry on 28 July 2018 (ChiCTR1800017398).
| S-EPMC7061121 | biostudies-literature
Project description:IntroductionCommunity detection of mild cognitive impairment (MCI) and Alzheimer's disease and related disorders (ADRD) is a challenge. While Gold Standard assessments are commonly used in research centers, these methods are time consuming, require extensive training, and are not practical in most clinical settings or in community-based research projects. Many of these methods require an informant (e.g., spouse, adult child) to provide ratings of the patients' cognitive and functional abilities. A patient-reported outcome that captures the presence of cognitive impairment and corresponds to Gold Standard assessments could improve case ascertainment, clinical care, and recruitment into clinical research. We tested the patient version of the Quick Dementia Rating System (QDRS) as a patient-reported outcome to detect MCI and ADRD.MethodsThe patient QDRS was validated in a sample of 261 consecutive patient-caregiver dyads compared with the informant version of the QDRS, the Clinical Dementia Rating (CDR), neuropsychological tests, and Gold Standard measures of function, behavior, and mood. Psychometric properties including item variability, floor and ceiling effects, construct, concurrent, and known-groups validity, and internal consistency were determined.ResultsThe patient QDRS strongly correlated with Gold Standard measures of cognition, function, mood, behavior, and global staging methods (p-values < .001) and had strong psychometric properties with excellent data quality and internal consistency (Cronbach alpha = 0.923, 95%CI:0.91-0.94). The patient QDRS had excellent agreement with the informant QDRS, the CDR and its sum of boxes (Intraclass Correlation Coefficients: 9.781-0.876). Receiver operator characteristic curves showed excellent discrimination between normal controls from CDR 0.5 (AUC:0.820;95% CI: 0.74-0.90) and for normal controls from any cognitive impairment (AUC:0.885;95% CI: 0.83-0.94).DiscussionThe patient QDRS validly and reliably differentiates individuals with and without cognitive impairment and can be completed by patients through all stages of dementia. The patient QDRS is highly correlated with Gold Standard measures of cognitive, function, behavior, and global staging. The patient QDRS provides a rapid method to screen patients for MCI and ADRD in clinical practice, determine study eligibility, improve case ascertainment in community studies.
| S-EPMC7561106 | biostudies-literature
Project description:IntroductionEarly identification of cognitive impairment (CI), including Alzheimer's disease and related dementias (ADRD), is a top public health priority. Yet, CI/ADRD is often undetected and underdiagnosed within primary care settings, and in health disparate populations. The MyCog paradigm is an iPad-based, self-administered, validated cognitive assessment based on the National Institutes of Health (NIH) Toolbox Cognition Battery and coupled with clinician decision-support tools that is specifically tailored for CI/ADRD detection within diverse, primary care settings.Methods and analysisWe will conduct a two-arm, primary care practice-randomised (N=24 practices; 45 257 active patients at the proposed practices), pragmatic trial among geographically diverse Oak Street Health sites to test the effectiveness of the MyCog paradigm to improve early detection CI/ADRD among low socioeconomic, black and Hispanic older adults compared with usual care. Participating practices randomised to the intervention arm will impart the MyCog paradigm as a new standard of care over a 3-year implementation period; as the cognitive component for Annual Wellness Visits and for any patient/informant-reported or healthcare provider-suspected cognitive concern. Rates of detected (cognitive test suggesting impairment) and/or diagnosed (relevant International Classification of Diseases-9/10 [ICD-9/10] code) cognitive deficits, impairments or dementias including ADRD will be our primary outcome of study compared between arms. Secondary outcomes will include ADRD severity (ie, mild or later stage), rates of cognitive-related referrals and rates of family member or caregiver involvement in ADRD care planning. We will use generalised linear mixed models to account for clustered study design. Secondary models will adjust for subject, clinic or visit-specific characteristics. We will use mixed-methods approaches to examine fidelity and cost-effectiveness of the MyCog paradigm.Ethics and disseminationThe Institutional Review Board at Advarra has approved the study protocol (Pro00064339). Results will be published in peer-reviewed journals and summaries will be provided to the funders of the study.Trial registration numberNCT05607732.
| S-EPMC10603543 | biostudies-literature
Project description:BackgroundVascular cognitive impairment, no dementia (VCIND) is a condition at risk for future dementia and should be the target of preventive strategies. Preliminary evidence suggests that acupuncture may be a clinically effective intervention for people with early-stage vascular cognitive impairment. We will do a multicenter, 6-month, drug-controlled, nonblinded, randomized, parallel-group trial to determine whether acupuncture is effective for improving cognitive function and quality of life for patients with VCIND.Methods/designA total of 216 eligible patients will be recruited and randomly assigned acupuncture for two sessions/week (n = 108) or citicoline 300 mg/day (n = 108) in a multicenter, 6-month trial. The primary endpoint is cognition (Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-cog)). Secondary endpoints include assessments of activities of daily living and behavioral symptoms (Clock Drawing Test (CDT), Activities of Daily Living (ADL) and Instrumental Activities of Daily Living scale (IADL)).DiscussionThis will be the first large-scale trial specifically evaluating acupuncture therapy in VCIND. If the study confirms the effectiveness and safety of acupuncture treatment, it will be important to examine how the acupuncture approach could most effectively be integrated into the provision of routine healthcare.Trial registrationThis study is registered as an International Standard Randomised Controlled Trial on 17 January 2014, number ISRCTN 82980206.
| S-EPMC4242470 | biostudies-literature
Project description:BACKGROUND:There is a growing need for an evidence-based approach to home support for people with dementia and their carers following diagnosis but research on the effectiveness and cost-effectiveness of different approaches is sparse. The Dementia Early Stage Cognitive Aids New Trial (DESCANT) will evaluate the clinical and cost-effectiveness of a range of memory aids, training and support to people with mild to moderate dementia and their carers at home and compares that intervention with treatment as usual. METHODS/DESIGN:This is a multi-site, pragmatic randomised trial preceded by a feasibility study and internal pilot. We aim to allocate at random 360 pairs comprising a person with mild to moderate dementia and an identified carer between the DESCANT intervention and treatment as usual. We assess participants at baseline, 13 and 26 weeks. The primary outcome measure is the Bristol Activities of Daily Living Scale; other participant outcomes include cognition, quality of life, activities of daily living and social networking; carer outcomes include quality of life, sense of competence and mental health. To enhance this quantitative evaluation we are conducting a qualitative component and a process evaluation to assess the implementation process and identify contextual factors associated with variation. DISCUSSION:The DESCANT intervention reflects current policy to enhance the capabilities of people with dementia after diagnosis and their carers. If it is clinically and cost-effective, its modest nature and cost will enhance the likelihood of it being incorporated into mainstream practice. TRIAL REGISTRATION:Current Controlled Trials, ISRCTN12591717 . Registered on 29 July 2016. Protocol number: 31288: North West - Haydock Research Ethics Committee, 20/06/2016, ref.: 16/NW/0389.
| S-EPMC6180589 | biostudies-other
Project description:Cancer-related cognitive impairment (CRCI) is a frequent side-effect of cancer treatment, with important consequences on patients' quality of life. Cognitive stimulation and physical activity are the most efficient in improving cognitive impairment, but they are challenging to generalize in hospitals' routine and to patients' needs and schedules. Moreover, the added value of a combination of these interventions needs to be more investigated. The Cog-Stim study is an interventional study investigating the feasibility of a web-based multimodal intervention (combining cognitive stimulation and physical activity for the improvement of cognitive complaints among breast-cancer patients currently treated with radiotherapy (n = 20). Patients will take part in a 12-week program, proposing two sessions per week of web-based cognitive stimulation (20 min/session with HappyNeuron®) and two sessions per week of web-based physical activity (30 min/session with Mooven® platform). Cognitive complaints (FACT-Cog) and objective cognitive functioning (CNS Vital Signs®), anxiety, depression (HADS), sleep disorders (ISI) and fatigue (FACIT-Fatigue) will be assessed before and after the intervention. The primary endpoint is the adherence rate to the intervention program. Patients' satisfaction, reasons for non-attrition and non-adherence to the program will also be assessed. The overall goal of this study is to collect information to develop web-based interventions for cognitive difficulties in supportive care units.
| S-EPMC8508392 | biostudies-literature