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Cog-VACCINE: Cognitive Training in Patients With Vascular Cognitive Impairment, no Dementia (Cog-VACCINE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02640716
Recruitment Status : Completed
First Posted : December 29, 2015
Results First Posted : July 23, 2020
Last Update Posted : July 23, 2020
Sponsor:
Collaborators:
Xuanwu Hospital, Beijing
Fu Xing Hospital, Capital Medical University
Information provided by (Responsible Party):
Yi Tang, Beijing Friendship Hospital

Brief Summary:
This study evaluates the efficacy and mechanism of internet-based cognitive training in patients with subcortical VCIND. Half of participants will receive multi-domain adaptive internet-based training program, while the other half will receive a fixed, primary difficulty level task.

Condition or disease Intervention/treatment Phase
Vascular Cognitive Impairment no Dementia Behavioral: multi-domain internet-based adaptive training program Behavioral: placebo program Not Applicable

Detailed Description:

Background:

Vascular cognitive impairment no dementia (VCIND) refers to cognitive deficits associated with underlying vascular causes which fall short of a dementia diagnosis. Because of its high prevalence and high progression to dementia, interest in VCIND has greatly expanded in recent years. Although it has been widely recognized that early intervention of VCIND holds the potential to delay or even reverse the cognitive impairment, no treatment is available yet. Executive dysfunction is the characteristic impairment in subcortical VCIND, and cognitive training significantly improved executive and other aspects of cognitive function in health older adults and patients with cognitive impairment. Whether and how cognitive training improves cognitive function in patients with VCIND remains largely unknown.

Objectives:

The primary objective of this double-blinded, randomized RCT is to assess whether internet-based cognitive training in patients with subcortical VCIND improves their cognitive abilities. The second objective is to evaluate the effect of cognitive training on neural plasticity, including brain activation and white matter integrity, which are assessed by functional and structural MRI. Finally, possible genetic and plasma biomarkers related to a positive effect or lack of effect of the training will be examined.

Patients and Methods:

The proposed study is a three-center, double-blinded, randomized controlled trial that will include 60 patients diagnosed with VCIND from the neurology clinics at Beijing Friendship hospital, Xuan Wu hospital, and geriatric clinic at Fu Xing hospital, Capital Medical University. The patients will be randomized to either a training or a control group. The intervention is internet-based cognitive training performed for 30 minutes over 35 sessions. Neuropsychological assessment and functional magnetic resonance imaging (MRI) will be performed before and 7 weeks after training.

Relevance:

Currently there is no known treatment available for VCIND. The proposed study is to determine the efficacy of cognitive training in patients with VCIND. Secondly, using functional and structural MRI, this study is to reveal the potential mechanism underlying cognitive training.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Cog-VACCINE Study: a Randomized Controlled Clinical Trial to Evaluate the Effect of Cognitive Training in Patients With Vascular Cognitive Impairment, no Dementia
Study Start Date : October 2015
Actual Primary Completion Date : May 8, 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia Vaccines

Arm Intervention/treatment
Active Comparator: training group
Intervention: Multi-domain adaptive internet-based training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. 5 x 30 minutes per week, for 7 weeks.
Behavioral: multi-domain internet-based adaptive training program
The cognitive training will be a multi-domain adaptive training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. Specific training paradigms include a time perception task, visual search task, attention blink, delayed mapping task, attention span task, Go-No go task, Stroop task, task switching, and name-face match task, among others. To maintain task difficulty, the tasks will be grouped based on the task difficulty in each domain. Furthermore, each task will have various difficulty levels.

Placebo Comparator: control group
Intervention: placebo program: a fixed, primary difficulty level task. 5 x 30 minutes per week, for 7 weeks.
Behavioral: placebo program
For the control group, tasks for processing speed and attention are included. Importantly, a fixed, primary difficulty level for all participants in the control group is set.




Primary Outcome Measures :
  1. Estimated Mean Change of the Montreal Cognitive Assessment (MoCA) [ Time Frame: Baseline and 7 weeks ]

    The study uses MoCA to assess changes in the global cognitive function after an intervention of cognitive training. Baseline and 7-week were the two relevant time points used in the calculation.

    The score of MoCA ranges from 0 to 30, and higher scores mean a better outcome.


  2. Estimated Mean Change of the Trail Making Test (TMT) B-A [ Time Frame: Baseline and 7 weeks ]
    The Trail Making Test is a commonly used neuropsychological test of visual attention and task-switching. In two timed tasks, subjects are asked to first connect numbers (Test A), then alternating numbers and letters (Test B), in sequential order as quickly as possible. Completion times, relating to cognitive processing speed and executive function (respectively) are represented as a difference (B-A). The Trail Making Test is a commonly used neuropsychological test of visual attention and task-switching. In two timed tasks, subjects are asked to first connect numbers (Test A), then alternating numbers and letters (Test B), in sequential order as quickly as possible. Completion times, relating to cognitive processing speed and executive function (respectively) are represented as a difference (B-A). The change from baseline at week 7 in the B-A difference is reported as a primar


Secondary Outcome Measures :
  1. Estimated Mean Changes in Left Hippocampal Volume [ Time Frame: Baseline and 7 weeks ]
    The left hippocampal volume on structural Magnetic Resonance Imaging (MRI) was measured by voxel-based morphometrics. The estimated mean changes in left hippocampal volume from baseline at week 7 is reported.

  2. Estimated Mean Change in Right Hippocampal Volume [ Time Frame: Baseline and 7 weeks ]
    The right hippocampal volume on structural Magnetic Resonance Imaging (MRI) was measured by voxel-based morphometrics. The estimated mean change in right hippocampal volume from baseline at week 7 is reported.

  3. Estimated Mean Change in Brain White Matter Integrity [ Time Frame: Baseline and 7 weeks ]

    The white matter microstructure was measured by diffusion tensor imaging (DTI) . The whole-brain average fractional anisotropy (FA) was calculated to show brain white matter integrity. The change of whole-brain average FA from baseline at week 7 is reported.

    Fractional anisotropy (FA) is a scalar value between zero and one that describes the degree of anisotropy of a diffusion process. A value of zero means that diffusion is isotropic, i.e. it is unrestricted (or equally restricted) in all directions.



Other Outcome Measures:
  1. Estimated Mean Change of MoCA [ Time Frame: Baseline and 6 months ]

    The participants will be followed up 6 months after recruitment. The training is not mandatory after 7 weeks, but the training details will be acquired from the online system. The change from baseline at month 6 in the MoCA difference is reported.

    The score of Moca ranges from 0 to 30, and higher scores mean a better outcome.




Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Literate Han Chinese, aged 50-78 years, with a consistent caregiver who accompanies the subject at least 4 days a week;
  • Complaint and/or informant report of cognitive impairment involving memory and/or other cognitive domains lasting for at least 3 months;
  • Neither normal nor demented according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, with a clinical dementia rating (CDR) ≥ 0.5 on at least one domain and global score ≤ 0.5; a Mini-Mental State Examination (MMSE) score ≥ 20 (primary school) or ≥ 24 (junior school or above);
  • Normal or slightly impaired activities of daily living as defined by a total score of ≤ 1.5 on the three functional CDR domains (home and hobbies, community affairs, and personal care).

The MRI entry criteria are as follows:

  • Multiple (≥ 3) supratentorial subcortical small infarcts (3-20 mm in diameter), with/without white matter lesions (WML) of any degree; or moderate to severe WML (score ≥ 2 according to the Fazekas rating scale) with/without small infarct;
  • Absence of cortical and watershed infarcts, hemorrhages, hydrocephalus, and WMLs with specific causes (e.g., multiple sclerosis);
  • No hippocampal or entorhinal cortex atrophy (score 0 according to the medial temporal lobe atrophy scale of Scheltens).

Exclusion Criteria:

  • severe aphasia, physical disabilities, or any other factor that may preclude completion of neuropsychological testing;
  • disorders other than subcortical VCIND that may affect cognition;
  • a Hamilton depression scale (HAMD) score >17 or schizophrenia;
  • new strokes within 3 months before baseline;
  • inherited or inflammatory small vessel disease;
  • clinically significant gastrointestinal, renal, hepatic, respiratory, infectious, endocrine, or cardiovascular system disease;
  • cancer, alcoholism, drug addiction;
  • use of medications that may affect cognitive functioning, including tranquilizers, anti-anxiolytics, hypnotics, nootropics, and cholinomimetic agents;
  • inability to undergo a brain MRI.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02640716


Locations
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China, Beijing
Beijing Friendship Hospital
Beijing, Beijing, China, 100050
Sponsors and Collaborators
Beijing Friendship Hospital
Xuanwu Hospital, Beijing
Fu Xing Hospital, Capital Medical University
Investigators
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Principal Investigator: Yi Tang, M.D., Ph.D. Beijing Friendship Hospital
  Study Documents (Full-Text)

Documents provided by Yi Tang, Beijing Friendship Hospital:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yi Tang, Dr., Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT02640716    
Other Study ID Numbers: 2015010
First Posted: December 29, 2015    Key Record Dates
Results First Posted: July 23, 2020
Last Update Posted: July 23, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Dementia
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders