Clinical trial NCT05704270: Computerized Cognitive Training to Protect Cognitive Function Among Hypertension Patients
Official title: The Efficacy of Computerized Cognitive Training in Patients With Hypertension and Cognitive Impairment, no Dementia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Hypertension
Keywords: Cognitive training
Digital health
Hypertension
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Wispirit Technology Co., Ltd
First posted: 2023-01-30
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypertension is an risk factor for cognitive impairment. The primary objective of this study is to evaluate the efficacy of 12-week computerized cognitive training in people with hypertension and mild cognitive impairment. The researchers will further investigate the long-term effects of cognitive training by prolonging the intervention for 24 weeks among a randomly selected sub-group.

Detailed description: This study is a double-blinded, randomized controlled trial. A total of 200 hypertension patients with mild cognitive impairment will be recruited to participate in this study after screening. These patients will be randomized to two arms under masking. The intervention arm will receive multi-domain adaptive cognitive training using a tablet. The control arm will receive an active control treatment and use the same tablet to receive the cognitive training tasks with weak difficulty change. Both arms will receive the same intervention dosage for 12 weeks, 5 times a week, and 30 minutes per time. After the 12-week intervention, the intervention arm will be re-randomized into two groups. One group will stop their intervention at 12 weeks; the other group will continue to receive the multi-domain adaptive cognitive training till the 24-week follow-up assessment.

The neuro-psychological assessment will be administered at baseline, 12-week, and 24-week assessments for all participants. The structural and functional MRI will be administered at baseline, 12 weeks, and 24 weeks to evaluate the effect of cognitive training on brain structure and function.

Eligibility criteria: Inclusion Criteria:

1. Older than 60 years;
2. Completed 6 or more years of education;
3. Untreated or under treatment hypertension;
4. Complaint of memory decline within 1 year;
5. Global cognitive score measured by the Montreal Cognitive Assessment is below 26;
6. Agree to receive cognitive function evaluation, randomization, and follow-up investigation as required;

Exclusion Criteria:

1. Unable to complete cognitive function evaluation due to vision, hearing, and other problems;
2. Have been diagnosed of dementia or MMSE score ≤ 20;
3. Unable to use the cognitive training equipment after 2 times instructions;
4. Alcohol abuse or taking drugs that could affect cognitive function (antihistamines, antipsychotics);
5. Diabetes patients;
6. Moderate to severe decrease in glomerular filtration rate (eGFR\<30 ml/min /1.73m2);
7. Systolic blood pressure ≥180 mmHg or/and diastolic blood pressure ≥110 mmHg; or orthostatic hypotension (defined as the third standing SBP\<100mmHg);
8. History of cardiovascular events or hospitalization due to cardiovascular diseases in the last 3 months;
9. Planned to receive coronary intervention, atrial fibrillation ablation or cardiac surgery within 6 months; or have received these intervention strategies in the last 3 months;
10. Symptomatic heart failure or left ventricular ejection fraction \<50%；
11. Atrial fibrillation confirmed by ECG with marked and severe onset of symptoms;
12. A history of stroke, or head injury in the last 6 months; past history of brain tumor or neurosurgery;
13. Past history of Parkinson's disease, Alzheimer's disease, schizophrenia, and epilepsy;
14. Have Ever undergone surgery under general anesthesia in the last three months;
15. Severe hepatic impairment or in critical condition patients with very poor prognosis whose expected survival is less than 6 months; or diagnosed of malignant tumor other than non-melanoma skin cancer in the last 2 years;
16. Contradictions for MRI examination: such as metal implantation, claustrophobia, etc.;
17. Unable to obtain an informed consent or currently taking part in other clinical trials

Primary outcomes:
measure: Global cognitive function change measured by BCAT in 12 weeks
timeFrame: 12 weeks after randomization
Secondary outcomes:
measure: Global cognitive function change measured by BCAT in 24 weeks
timeFrame: 24 weeks after randomization
measure: Sub-domain cognitive function improvement including memory, attention, and execution memory
timeFrame: 12 weeks, 24 weeks after randomization
measure: Cognitive score change
timeFrame: 12 weeks, 24 weeks after randomization
measure: Self-efficacy score
timeFrame: 12 weeks, 24 weeks after randomization
measure: Quality of life score
timeFrame: 12 weeks, 24 weeks after randomization
measure: Anxiety score
timeFrame: 12 weeks, 24 weeks after randomization
measure: Depression score
timeFrame: 12 weeks, 24 weeks after randomization
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
city: Shanghai
country: China
facility: Ruijing Hospital, Shanghai Jiaotong University School of Medicine
Study officials:
affiliation: Beijing Anzhen Hospital
name: Chang sheng Ma
role: PRINCIPAL_INVESTIGATOR
References: