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

NCT02640716 | Completed Results

• 1 other identifier: 2015010
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Cognitive Impairment no Dementia

Outcome Measures

Primary Outcomes (2)

• Estimated Mean Change of the Montreal Cognitive Assessment (MoCA)

  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.

  Baseline and 7 weeks

• Estimated Mean Change of the Trail Making Test (TMT) 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 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

  Baseline and 7 weeks

Secondary Outcomes (3)

• Estimated Mean Changes in Left Hippocampal Volume

  Baseline and 7 weeks

• Estimated Mean Change in Right Hippocampal Volume

  Baseline and 7 weeks

• Estimated Mean Change in Brain White Matter Integrity

  Baseline and 7 weeks

Other Outcomes (1)

• Estimated Mean Change of MoCA

  Baseline and 6 months

Study Arms (2)

training group

ACTIVE COMPARATOR

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

control group

PLACEBO COMPARATOR

Intervention: placebo program: a fixed, primary difficulty level task. 5 x 30 minutes per week, for 7 weeks.

Behavioral: placebo program

Interventions

multi-domain internet-based adaptive training program BEHAVIORAL

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.

training group

placebo program BEHAVIORAL

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.

control group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead
• Xuanwu Hospital, Beijing: collaborator
• Fu Xing Hospital, Capital Medical University: collaborator

Study Sites (1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (2)

• Li QG, Xing Y, Zhu ZD, Fei XL, Tang Y, Lu J. Effects of computerized cognitive training on functional brain networks in patients with vascular cognitive impairment and no dementia. CNS Neurosci Ther. 2024 Jun;30(6):e14779. doi: 10.1111/cns.14779.

  PMID: 38828650 DERIVED

• Tang Y, Zhu Z, Liu Q, Li F, Yang J, Li F, Xing Y, Jia J. The efficacy of Cognitive training in patients with VAsCular Cognitive Impairment, No dEmentia (the Cog-VACCINE study): study protocol for a randomized controlled trial. Trials. 2016 Aug 5;17(1):392. doi: 10.1186/s13063-016-1523-x.

  PMID: 27496126 DERIVED

Results Point of Contact

• Title: Dr. Yi Tang
• Organization: Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China

tangyi@xwhosp.org

+86 10 83199456

Study Officials

• Yi Tang, M.D., Ph.D.

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: December 29, 2015
• Study Start: October 1, 2015
• Primary Completion: May 8, 2017
• Study Completion: December 1, 2017
• Last Updated: July 23, 2020
• Results First Posted: July 23, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)