Cognitive Decline and Underlying Mechanisms in Asymptomatic Intracranial Artery Stenosis Patients

Anhui Medical University

Status: Enrolling

Conditions: Cerebrovascular Event; Asymptomatic Intracranial Stenosis; Cognitive Impairment

Treatments: Drug: Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin

Study type: Observational

Funder types: Other

Identifiers

NCT05504330

Anhui-AsIA-cohort

Details and patient eligibility

About

The purpose of this study is to explore the mechanism of cognitive impairment in patients with asymptomatic intracranial atherosclerotic stenosis(ICAS),and to examine the natural history and the pathogenesis of asymptomatic ICAS.

Full description

All participants underwent a medical evaluation that included routine laboratory studies before and after 1- and 2-years follow-up. Upon meeting the inclusion criteria and providing informed consent, each participant will complete a battery measure of neuropsychological tests, blood sample collection, and magnetic resonance imaging scan after enrollment and after 1- and 2-years follow-up.

About 100 participants were included in this study. A series of neuropsychological tests were obtained by a trained investigator to assess. The tests include the evaluation of global cognitive function and multiple individual cognitive domains. The various tasks and questionnaires to measure cognition function including Montreal Cognitive Assessment(MoCA), Mini Mental State Examination(MMSE), Chinese Auditory Verbal Learning Test(CAVLT), Digital Span Test(DST), Symbol digital modalities test(SDMT), Stroop color test(Stroop test), Color trail test(CTT), Rey-Osterrieth Complex Figure(ROCF), Judgment of Line Orientation (JoLO), Verbal Fluency Test(VFT), Boston Naming Test (BNT) , Lateralized attention network test(LANT) etc, at the same time, the investigators also pay attention to the evaluation of participants' emotions by Hamilton Anxiety Scale(HAMA),Hamilton Depression Scale(HAMD). Furthermore, the memory as the primary outcome measure, this study focused on the immediate memory, delayed memory and recognition memory of patients with asymptomatic ICAS. Blood sample will be collected for biological multiomics research. The patients will receive a magnetic resonance imaging scan in multi-modalities.

After 1 and 2 years follow-up,the participants will be interviewed to obtain the same assessments, blood sample and magnetic resonance imaging scan in multi-modalities as before.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with intracranial stenosis which was defined as stenosis of 50% or more in Intracranial segment of internal carotid artery(C6-C7) and middle cerebral artery (M1).
2. The degree of stenosis was measured by transcranial doppler, computed magnetic resonance angiography (MRA),tomography angiography (CTA) and digital subtraction angiography (DSA).

Exclusion criteria

1. History of stroke,transient ischemic attack,seizures or unexplained loss of consciousness.
2. Organic brain defects on MRI T1 or T2 images.
3. Any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder).
4. Implanted pacemaker,medication pump,vagal stimulator,deep brain stimulator. History of substance abuse within the last 6 months.

Trial design

100 participants in 2 patient groups

Patient Group

Description:

Asymptomatic intracranial stenosis patients who receive standard medical treatment without stenting

Treatment:

Drug: Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin

Healthy Control

Description:

Healthy control are free from intracranial stenosis