Clinical trial NCT05374642: Atrial Fibrillation Follow-up Investigation to Recover Memory and learnING Trial
Official title: Randomized Controlled Trial of Computerized Cognitive Training in Patients With Atrial Fibrillation With Cognitive Impairment But Without Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Atrial Fibrillation
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Wispirit Technology Co., Ltd
First posted: 2022-05-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate the effectiveness of cognitive training in people with atrial fibrillation and cognitive decline over 12-week cognitive training. Moreover, the investigators will explore whether the training effect can be maintained.

Detailed description: Introduction: Cognitive impairment is a clinical condition characterized of a reduction in memory and/or other cognitive processes that are insufficiently severe to be diagnosed as dementia.The prevalence of dementia among people over 65 years old in China is 5.14% , while the prevalence of mild cognitive impairment is 20.8%. The risk of cognitive impairment and dementia in patients with atrial fibrillation is significantly higher than that those in the same age group, even after adjusted stroke and other common risk factors such as hypertension and diabetes. At present, the effectiveness of cognitive training in patients with atrial fibrillation complicated with cognitive impairment is not clear.

Objectives: The objective of the study is to evaluate whether cognitive training could lead cognitive improvement in patients with cognitive impairment and atrial fibrillation.

Patients and Methods: The proposed study is a double blinded, randomized and controlled trial that will include 200 patients with cognitive impairment and atrial fibrillation. The groups will be randomized to either intervention or active-control group. Both groups will receive computerized cognitive training performed for 30 minutes x 5 times/week over 12 weeks. A neuropsychological assessment will be administered at baseline and week 12 and 24 after the intervention. The structural and functional MRI will be performed at baseline and week 12 after intervention for a sub-study on the effect of cognitive training on brain structure and function.

Eligibility criteria: Inclusion Criteria:

1. Older than 18 years;
2. Completion of 6 or more years of education;
3. Atrial fibrillation confirmed by ECG ;
4. Complain of memory decline within 1 year;
5. The score of any cognitive domain in the processing speed, episodic memory, working memory, and visual-spatial tested by the Basic Cognitive Ability Assessment (BCAT) is 1SD less than the average of the normal population;
6. Agree to receive cognitive function testing and randomization, be able to receive follow-up as required

Exclusion Criteria:

1. Unable to complete the test due to vision, hearing and other problems;
2. Dementia or MMSE Scale ≤ 20;
3. Alcohol abuse or taking drugs that affect cognitive function (antihistamines, antipsychotics);
4. Cannot master the method of cognitive training tool after 2 times, 1 hour each time training instruction;
5. Planned atrial fibrillation ablation within 3 months or received ablation in the last 3 months;
6. CHA2DS2-VASc score ≥ 2 (for female ≥ 3), but refuses anticoagulation or has anticoagulation contraindications;
7. General anaesthesia in the last 3 months;
8. A history of stroke and head injury in the last 6 months;
9. Past history of Parkinson's disease, schizophrenia, and epilepsy;
10. Previous neurosurgery or a history of head tumor;
11. Contraindications for MRI examination: such as metal implantation, claustrophobia, etc.;
12. No family members to assist the patients to do the training course

Primary outcomes:
measure: global cognitive change in 12 weeks
timeFrame: 12 weeks after randomization
Secondary outcomes:
measure: global cognitive change in 24 weeks
timeFrame: 24 weeks after randomization
measure: domain cognitive change
timeFrame: 12 weeks, 24 weeks after randomization
measure: cognitive score change
timeFrame: 12 weeks, 24 weeks after randomization
measure: self-efficacy scores
timeFrame: 12 weeks, 24 weeks after randomization
measure: quality of life scores
timeFrame: 12 weeks, 24 weeks after randomization
measure: anxiety and depression scores
timeFrame: 12 weeks, 24 weeks after randomization
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
References:
citation: Jia J, Zhou A, Wei C, Jia X, Wang F, Li F, Wu X, Mok V, Gauthier S, Tang M, Chu L, Zhou Y, Zhou C, Cui Y, Wang Q, Wang W, Yin P, Hu N, Zuo X, Song H, Qin W, Wu L, Li D, Jia L, Song J, Han Y, Xing Y, Yang P, Li Y, Qiao Y, Tang Y, Lv J, Dong X. The prevalence of mild cognitive impairment and its etiological subtypes in elderly Chinese. Alzheimers Dement. 2014 Jul;10(4):439-447. doi: 10.1016/j.jalz.2013.09.008. Epub 2014 Jan 10.
citation: de Bruijn RF, Heeringa J, Wolters FJ, Franco OH, Stricker BH, Hofman A, Koudstaal PJ, Ikram MA. Association Between Atrial Fibrillation and Dementia in the General Population. JAMA Neurol. 2015 Nov;72(11):1288-94. doi: 10.1001/jamaneurol.2015.2161.
citation: Chen LY, Norby FL, Gottesman RF, Mosley TH, Soliman EZ, Agarwal SK, Loehr LR, Folsom AR, Coresh J, Alonso A. Association of Atrial Fibrillation With Cognitive Decline and Dementia Over 20 Years: The ARIC-NCS (Atherosclerosis Risk in Communities Neurocognitive Study). J Am Heart Assoc. 2018 Mar 7;7(6):e007301. doi: 10.1161/JAHA.117.007301.
citation: Sherman DS, Mauser J, Nuno M, Sherzai D. The Efficacy of Cognitive Intervention in Mild Cognitive Impairment (MCI): a Meta-Analysis of Outcomes on Neuropsychological Measures. Neuropsychol Rev. 2017 Dec;27(4):440-484. doi: 10.1007/s11065-017-9363-3. Epub 2017 Dec 27.