N/A
N=60
Cog-VACCINE: Cognitive Training in Patients With Vascular Cognitive Impairment, no Dementia
Vascular Cognitive Impairment no Dementia
Bottom Line
View on ClinicalTrials.gov: NCT02640716 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Estimated Mean Change of the Montreal Cognitive Assessment (MoCA) — 3.356; -0.085 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- multi-domain internet-based adaptive training program (Behavioral); placebo program (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Beijing Friendship Hospital
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Estimated Mean Change of the Montreal Cognitive Assessment (MoCA) |
3.356; -0.085 | — |
| PRIMARY Estimated Mean Change of the Trail Making Test (TMT) B-A |
-5.958; -10.702 | — |
| SECONDARY Estimated Mean Changes in Left Hippocampal Volume |
-105.673; -70.266 | — |
| SECONDARY Estimated Mean Change in Right Hippocampal Volume |
-0.276; -103.716 | — |
| SECONDARY Estimated Mean Change in Brain White Matter Integrity |
-0.008; 0.004 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02640716). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.