Atrial Fibrillation Follow-up Investigation to Recover Memory and learnING Trial

Atrial Fibrillation Clinical Trial

— AFFIRMING  

Official title:

Randomized Controlled Trial of Computerized Cognitive Training in Patients With Atrial Fibrillation With Cognitive Impairment But Without Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05374642
• Other study ID #: 2022-AFFIRMING
• Status: Completed
• Phase: N/A
• Start date: September 19, 2022
• Est. completion date: March 27, 2024

Study information

• Verified date: May 2024
• Source: Beijing Anzhen Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 27, 2024
• Est. primary completion date: December 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cognitive Dysfunction
• Cognitive Impairment

Intervention

Behavioral:
• cognitive training
tablet-based cognitive training for 12 weeks, 30 minutes each time, at least 5 times a week
• active control
tablet-based cognitive training tasks with weak or no difficulty changes, 5 times a week, 30 minutes each time for 12 weeks

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital	Beijing Wispirit Technology Co., Ltd

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	global cognitive change in 12 weeks	The percentage of patients whose global cognitive function measured at 12 weeks after intervention improves 0.67 SD compared to that measured at baseline by basic cognitive ability test (BCAT)	12 weeks after randomization
Secondary	global cognitive change in 24 weeks	The percentage of patients whose global cognitive function improved at 24 weeks	24 weeks after randomization
Secondary	domain cognitive change	The percentage of patients whose cognitive function improved in any domain at 12 weeks and at 24 weeks;	12 weeks, 24 weeks after randomization
Secondary	cognitive score change	Changes in global cognitive function scores at 12 weeks and at 24 weeks	12 weeks, 24 weeks after randomization
Secondary	self-efficacy scores	Changes in the patient's self-efficacy scores compared with baseline at 12 weeks and at 24 weeks. The General Self-Efficacy scale ranged from 10 to 40, and higher scores mean better self-efficacy.	12 weeks, 24 weeks after randomization
Secondary	quality of life scores	Changes in the patient's quality of life scores compared with baseline at 12 weeks and at 24 weeks. quality of life will be measured using EQ-5D-3L(EuroQol 5-Dimensional 3 level version).	12 weeks, 24 weeks after randomization
Secondary	anxiety and depression scores	Changes in the patient's anxiety and depression scores compared with baseline at 12 weeks and at 24 weeks. Anxiety status will be measured using the GAD-7 questionnaire which ranges from 0 to 21, with a higher score representing more anxiety. Depression status will be measured using the PHQ-9 questionnaire which ranges from 0 to 27, with a higher score representing more depression.	12 weeks, 24 weeks after randomization