CTA-MCI: Cognitive Control Training in Patients With Amnestic Mild Cognitive Impairment(CTA-MCI)
CTA-MCI
The CTA-MCI Study: a Randomized Controlled Clinical Trial to Evaluate the Effect of Cognitive Control Training on Episodic Memory Function in Patients With Amnestic Mild Cognitive Impairment
1 other identifier
interventional
70
1 country
1
Brief Summary
This study evaluates the efficacy and mechanism of internet-based cognitive control training on episodic memory function in patients with amnestic Mild Cognitive Impairment(aMCI). Half of participants will receive adaptive internet-based cognitive control training program, while the other half will receive a fixed, primary difficulty level task.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2017
CompletedFirst Posted
Study publicly available on registry
April 28, 2017
CompletedStudy Start
First participant enrolled
July 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedFebruary 19, 2019
January 1, 2019
2.3 years
April 1, 2017
February 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Montreal Cognitive Assessment (MoCA)
The study uses MoCA to assess changes in the global cognitive function after an intervention of cognitive control training
12 weeks
Auditory Verbal Learning Test (AVLT)
The study uses AVLT to assess changes in the episodic memory function after an intervention of cognitive control training
12 weeks
Secondary Outcomes (4)
Gray matter volume
12 weeks
White matter Integrity
12 weeks
Brain response change
12 weeks
Functional connectivity across regions
12 weeks
Other Outcomes (5)
MoCA
6 months
AVLT
6 months
Gray matter volume
6 months
- +2 more other outcomes
Study Arms (2)
training group
ACTIVE COMPARATORIntervention: Internet-based adaptive cognitive control training program. 5 x 30 minutes per week, for 12 weeks.
control group
PLACEBO COMPARATORIntervention: placebo program: a fixed, primary difficulty level task. 5 x 30 minutes per week, for 12 weeks.
Interventions
The cognitive training will be an internet-based adaptive cognitive control training program, specific training paradigms include Flanker, 1-back, 2-back. To maintain task difficulty, the tasks will be grouped based on the task difficulty. Furthermore, each task will have various difficulty levels.
For the control group, a fixed, primary difficulty level program for all participants is set.
Eligibility Criteria
You may qualify if:
- Literate Chinese, aged 50 years and older
- Complaint about memory loss and confirmed by an informant
- Cognitive impairment in memory domain, adjusted for age and education
- Normal or near-normal performance on general cognitive function and no or minimum impairment of daily life activities
- Clinical dementia rating (CDR) =0.5, Mini-Mental State Examination (MMSE) score ≥ 20 (primary school) or ≥ 24 (junior school or above)
- Failure to meet the criteria for dementia
You may not qualify if:
- history of clinically significant stroke
- neurological diseases that may lead to neurological distortion, including schizophrenia, severe anxiety or depression, frontotemporal dementia，Huntington disease, brain tumor, parking disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, brain trauma, normal pressure hydrocephalus
- systemic diseases that may lead to neurological distortion, including hypothyroidism, folic acid deficiency, vitamin B12 deficiency, severe anemia, specific infection such as HIV and syphilis
- clinically significant gastrointestinal, renal, hepatic, respiratory, endocrine, or cardiovascular system disease;
- cancer, alcoholism, drug addiction;
- severe aphasia, physical disabilities, or any other factor that may preclude completion of neuropsychological testing;
- use of medications that may affect cognitive functioning, including tranquilizers, anti-anxiolytics, hypnotics, nootropics, and cholinomimetic agents;
- inability to undergo a brain MRI.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China
Related Publications (1)
Zhang K, Wang J, Peng G, Liu P, He F, Zhu Z, Luo B. Effect of cognitive training on episodic memory retrieval in amnestic mild cognitive impairment patients: study protocol for a clinical randomized controlled trial. Trials. 2019 Jan 8;20(1):26. doi: 10.1186/s13063-018-3143-0.
PMID: 30621794DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Benyan Luo, Ph.D.
The First Affiliated Hospital, Zhejiang University
Central Study Contacts
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
- SPONSOR
Study Record Dates
First Submitted
April 1, 2017
First Posted
April 28, 2017
Study Start
July 9, 2017
Primary Completion
November 1, 2019
Study Completion
April 1, 2020
Last Updated
February 19, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share