Clinical trial NCT02640716: Cog-VACCINE: Cognitive Training in Patients With Vascular Cognitive Impairment, no Dementia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Cognitive Impairment no Dementia
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Xuanwu Hospital, Beijing
name: Fu Xing Hospital, Capital Medical University
First posted: 2015-12-29
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Estimated Mean Change of the Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline and 7 weeks
measure: Estimated Mean Change of the Trail Making Test (TMT) B-A
timeFrame: Baseline and 7 weeks
Secondary outcomes:
measure: Estimated Mean Changes in Left Hippocampal Volume
timeFrame: Baseline and 7 weeks
measure: Estimated Mean Change in Right Hippocampal Volume
timeFrame: Baseline and 7 weeks
measure: Estimated Mean Change in Brain White Matter Integrity
timeFrame: Baseline and 7 weeks
Other outcomes:
measure: Estimated Mean Change of MoCA
timeFrame: Baseline and 6 months
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Yi Tang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.