Plain English Summary
Background and study aims
Cerebrovascular disease (conditions that are a result of problems with the blood vessels in the brain) and ischemic brain injury caused by heart disease are common causes of dementia and decline in cognitive (mental) function in the elderly. Reduced mental function without dementia (vascular cognitive impairment, no dementia [VCIND]) comprises a range of cognitive disorders related to cerebral vessel disease. A study on the progression of cognitive and functional impairment showed that 2% of VCIND patients died and 46% developed dementia. Unlike many other cognitive disorders, VCIND could be prevented or the course of cognitive decline could be improved. However, apart from controlling vascular risk factors, the effects of drug treatment on patients with VCIND are uncertain. Acupuncture is widely used for patients with neuropsychiatric disorders but there is a lack of information about its effectiveness. The aim of this study is to assess the effectiveness of acupuncture in the treatment of VCIND patients.
Who can participate?
Male and female patients aged 50-85 diagnosed with VCIND.
What does the study involve?
Participants will be randomly allocated to receive either acupuncture or a drug. The acupuncture group will receive two acupuncture sessions per week for 3 months. The drug group will be treated with oral citicoline three times per day for 3 months.
What are the possible benefits and risks of participating?
The results of this study may contribute to the future improvement of patient care. Participants may benefit from improved functional status and quality of life. The risks of taking part are minimal. Citicoline has been recommended in some European countries with a reliable safety profile. Acupuncture is a relatively safe treatment when given by properly trained clinicians. Occasionally acupuncture could make people feel nauseous or faint during or after treatment. Participants are warned of potential side effects before consenting to have the drug or acupuncture.
Where is the study run from?
This study will be carried out at four different centers in China: Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing Chinese Medicine Hospital in Huairou District, the Beijing Fengtai Hospital of Integrative Medicine, and Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine.
When is the study starting and how long is it expected to run for?
The study started in July 2013 will be recruiting patients until December 2015. The study is expected to complete in October 2016.
Who is funding the study?
Beijing Municipal Science & Technology Commission (China).
Who is the main contact?
Dr Liu Cun-Zhi
lcz623780@126.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Liu Cun-Zhi
ORCID ID
Contact details
Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
23 Meishuguanhou Street
Dongcheng District
Beijing
100010
China
-
lcz623780@126.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
z131107002213034
Study information
Scientific title
Effect of acupuncture treatment on Vascular Cognitive Impairment, No Dementia: a multi-center, randomized, controlled trial
Acronym
VCIND
Study hypothesis
To investigate the effect of acupuncture on vascular cognitive impairment no dementia (VCIND).
Ethics approval
Ethics Committee of the Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, 22/03/2013, ref: 201317
Study design
Multi-center randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Vascular cognitive impairment not dementia（VCIND）
Intervention
All participants will be randomized to two different groups:
1. Acupuncture group: this group of patients will receive two acupuncture sessions per week for 3 months.
2. Drug group: this group of patients will receive oral citicoline 0.1g per time, 3 times per day for 3 months.
Intervention type
Mixed
Phase
Drug names
Primary outcome measure
The cognitive section of the Alzheimer Disease Assessment Scale (ADAS-Cog) will be assessed at baseline, the end of treatment and 3 months after the end of treatment.
Secondary outcome measures
1. Clock drawing test (CDT) will be assessed at baseline, the end of treatment and 3 months after the end of treatment.
2. Ability of daily living (ADL) and instrumental activities of daily living scale (IADL) will be assessed at baseline, the end of treatment and 3 months after the end of treatment.
Participants will report adverse events they experience, including discomfort or bruising at the sites of needle insertion, nausea, or feeling faint after each acupuncture treatment. Adverse drug reactions like nausea and vomiting, dizziness, dry mouth and itching will also be recorded.
Overall trial start date
01/07/2013
Overall trial end date
30/10/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 55-85 years, either sex
2. Hachinski score ≥7
3. Evidence of vascular lesions on neuroradiology
4. Fluency in language sufficient to reliably complete all study assessments
5. Mini-Mental State Examination (MMSE) score >dementia threshold corrected based on educational year (>17 scores, >20 scores and >24 scores for 0, ≤6, and>6 educational years, respectively)
6. Montreal Cognitive Assessment (MoCA) <26 scores for >12 educational years (or <25 scores for≤12 educational years)
7. Written and informed consent
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
216
Participant exclusion criteria
1. History of mental diseases (e.g., schizophrenia, serious anxiety and depression)
2. Patients with Alzheimer's disease, Parkinson's disease, frontotemporal dementia or Huntington's disease
3. Patients with epilepsy and/or ever having antiepileptic drugs
4. Presence of serious heart diseases, kidney diseases or liver diseases
Recruitment start date
01/07/2013
Recruitment end date
01/12/2015
Locations
Countries of recruitment
China
Trial participating centre
Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
Beijing
100010
China
Sponsor information
Organisation
Beijing Municipal Science & Technology Commission (China)
Sponsor details
No. 7
Building 2
Evergreen Road
Haidian District
Beijing
100010
China
+86 (0)10 66153395
xmgl_2010@163.com
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Beijing Municipal Science & Technology Commission (China)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Cun-Zhi Liu (lcz623780@126.com). The data will become available from the publication of the article to a year later. All subjects' data will be shared including with all participants, as electronic documents, and by e-mail.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25391431
2019 results in: http://www.ncbi.nlm.nih.gov/pubmed/30672317 [added 18/02/2019]
Publication citations
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Protocol
Yang BF, Zeng XH, Liu Y, Fu QN, He T, Li F, Shi GX, Liu BZ, Sun SF, Wang J, Xiao L, Deng YM, Liu CZ, Effect of acupuncture treatment on vascular cognitive impairment without dementia: study protocol for a randomized controlled trial., Trials, 2014, 15, 1, 442, doi: 10.1186/1745-6215-15-442.