Cognitive Decline and Underlying Mechanisms in Asymptomatic Intracranial Artery Stenosis Patients
NCT05504330, Unknown, Anhui Medical University
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Cognitive Decline and Underlying Mechanisms in Asymptomatic Intracranial Artery Stenosis Patients | ClinicalTrials.gov |
| NCT number | NCT05504330 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Enrollment | 100 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Anhui Medical University | ClinicalTrials.gov |
| Conditions | Asymptomatic Intracranial Stenosis, Cognitive Impairment, Cerebrovascular Event | ClinicalTrials.gov |
| Interventions | Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin | ClinicalTrials.gov |
| First posted | 2022-08-17 | ClinicalTrials.gov |
| Last updated | 2024-04-03 | ClinicalTrials.gov |
Registered outcomes 24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | The changes in Memory | baseline, 1 and 2 years after follow-up | The changes in Memory function will constitute one of the main indicators of research results, which will be used to evaluate the follow-up results of the standard treatment regimen. The investigators will use the Chinese Auditory Verbal Learning Test (CAVLT) to evaluate the immediate, delayed and recognition memory of patients with asymptomatic ICAS to evaluate the immediate, delayed and recognition memory of patients with ICAS. | ClinicalTrials.gov |
| Primary | Occurrence of ischemic cerebrovascular events | baseline, 1 and 2 years after follow-up | The changes in occurrence of ischemic cerebrovascular events constitute another major indicator of research result. The new responsible vascular cerebrovascular events during the follow-up period are also the clinical information the investigators pay attention to, including transient ischemic attack (TIA) and stroke. | ClinicalTrials.gov |
| Secondary | MoCA (Montreal Cognitive Assessment) | baseline, 1 and 2 years after follow-up | The changes in MoCA will constitute the secondary research outcome. MoCA was based on clinical experience and reference to the MMSE cognitive items and scores, and the final version was finalized in November 2004. The investigators adopted a localized version (Mandarin version，includes 2 alternative versions) in line with the Chinese cultural background.It includes 11 inspection items in 8 cognitive fields, including visual structure skills, executive function, naming, attention and calculation, language, abstract thinking, memory, and orientation. With a total score of 30 or more than 26, it is normal. Anyone who has been education for less than 12 years will need to add one point to his final score. The final score of the higher the better. | ClinicalTrials.gov |
| Secondary | MMSE (Mini Mental State Examination) | baseline, 1 and 2 years after follow-up | The changes in MMSE will also constitute the secondary research outcome.The full name of MMSE is mini-mental state examination, and the scale consists of 30 subject, include the following seven aspects: time orientation, place orientation,immediate memory,attention and calculation,delay memory,language, visual space.One point is awarded for each question correctly answered during MMSE evaluation. If subject give the wrong answer or don't know answer he/she awarded 0 score, scope of scale score of 0 to 30 points. The higher the score, the better. In this study, the investigators suspect that scores would decrease after follow-up. | ClinicalTrials.gov |
| Secondary | DST (Digital Span Test; Forward and Backward) | baseline, 1 and 2 years after follow-up | The changes in DST will constitute the secondary research outcome. Digital span test (DST) was commonly used to evaluate attention ability and instantaneous memory ability. There are two types of test: forward(0-14) and backward(0-13).In the forward test, the subjects were asked to retell the the digits immediately after hearing it until they could not be repeated correctly.In backward test, the subjects were asked to repeat a set of numbers in reverse order until they could not be repeated correctly. The length of the last set of Numbers correctly repeated by the subjects was the final score, forward and backward are counted separately. The higher the score, the better. In this study, the investigators suspect that scores would decrease after follow-up. | ClinicalTrials.gov |
| Secondary | SDMT (Symbol digital modalities test) | baseline, 1 and 2 years after follow-up | The changes in The Symbol digital modalities test (SDMT) will constitute the secondary research outcome measure. The investigators intend to explore the cognitive processing speed of patients with SDMT, and evaluate it through a 90s test. The main indicators of concern are the amount of correctly completed conversions within 90s and the maximum continuous number of correctly completed conversions. | ClinicalTrials.gov |
| Secondary | The Stroop color test | baseline, 1 and 2 years after follow-up | The changes in The Stroop color test will constitute the secondary research outcome measure.The Stroop color word test was developed by Stroop in 1935 and is used to evaluate the attention function of the subject. The subject is required to correctly read the target color on the stimulus card and record the completion time. The final completion time is the score of the participant. The shorter the time used, the better the performance of the subjects | ClinicalTrials.gov |
| Secondary | CTT (Color Trail Test) | baseline, 1 and 2 years after follow-up | The changes in CTT will constitute the secondary research outcome. The Color Trail Test (CTT) is divided into two parts, part A and part B. Part A requires the subject to connect 25 Numbers on the paper in sequence, and part B requires the subject to connect 25 Numbers of different colors alternately in sequence. The time it takes for the subject to complete all the Numbers is the subject's final score.In this study, the investigators suspect that scores would decrease after follow-up. | ClinicalTrials.gov |
| Secondary | ROCF (Rey-Osterrieth Complex Figure) | baseline, 1 and 2 years after follow-up | The changes in The Rey-Osterrieth complex figure will constitute the secondary research outcome measure. The Rey-Osterrieth Complex Figure Test (ROCF), which was developed by Rey in 1941 and standardized by Osterrieth in 1944, is a widely used neuropsychological test for the evaluation of visuospatial constructional ability and visual memory. At the first step, subjects are given the ROCF stimulus card, and then asked to draw the same figure. Subsequently, they are instructed to draw what they remembered within 10 minutes. Finally, score according to the unified standard. | ClinicalTrials.gov |
| Secondary | JoLO (Judgment of Line Orientation) | baseline, 1 and 2 years after follow-up | The changes in Judgment of Line Orientation will constitute the secondary research outcome measure. The Judgment of Line Orientation (JLO) test is one of the most widely used measures for the assessment of visuospatial perception, and is often used for visuospatial defects after right hemisphere injury. | ClinicalTrials.gov |
| Secondary | VFT (Verbal Fluency Test) | baseline, 1 and 2 years after follow-up | The changes in The Verbal Fluency Test (VFT) will constitute the secondary research outcome measure. The VFT can be used to evaluate the frontal lobe fluency of patients, mainly including semantic verbal fluency and phonemic verbal fluency. | ClinicalTrials.gov |
| Secondary | BNT (Boston Naming Test) | baseline, 1 and 2 years after follow-up | The changes in The Verbal Fluency Test (VFT) will constitute the secondary research outcome measure. The VFT can be used to evaluate the frontal lobe fluency of patients, mainly including semantic verbal fluency and phonemic verbal fluency. | ClinicalTrials.gov |
| Secondary | LANT (Lateralized attention network test) | baseline, 1 and 2 years after follow-up | Attention is an important part of human cognitive function. The vigilant attention network, directed attention network and executive function network in bilateral cerebral hemispheres of asymptomatic ICAS patients can be measured by LANT. | ClinicalTrials.gov |
| Secondary | HAMD (Hamilton Depression Scale) | baseline, 1 and 2 years after follow-up | The changes in HAMD will constitute the secondary research outcome. Hamilton Depression Scale (HAMD) compiled by Hamilton in 1960, is the most common clinical to assess Depression Scale. In this study, 17 versions were selected, and there were 17 questions. The subjects were assessed for their depression in the past week. Each question scored between 0 and 4 points.Higher scores indicate more depressive symptoms. | ClinicalTrials.gov |
| Secondary | HAMA (Hamilton Anxiety Scale) | baseline, 1 and 2 years after follow-up | The changes in HAMA will constitute the secondary research outcome. Hamilton Anxiety Scale (HAMA) was compiled by Hamilton in 1959.It was one of the most commonly used scales in psychiatric clinic, including 14 items. It is often used in clinical diagnosis and degree classification of anxiety disorder. The subjects were assessed for their anxiety in the past week. Each question scored between 0 and 4 points. The higher the score, the more symptoms of anxiety. | ClinicalTrials.gov |
| Secondary | MRI measure- resting state MRI images | baseline, 1 and 2 years after follow-up | The resting state magnetic resonance data were collected to compare the neuroimaging differences between the patients and healthy control groups. | ClinicalTrials.gov |
| Secondary | MRI measures-structural phase MRI images | baseline, 1 and 2 years after follow-up | The structural phase magnetic resonance data were collected to compare the neuroimaging differences between the patients and healthy control groups. | ClinicalTrials.gov |
| Secondary | MRI measures-3D pCASL images | baseline, 1 and 2 years after follow-up | The three-dimensional pseudo continuous Arterial Spin Labeling (3D pCASL) data were collected to compare the differences in cerebral perfusion between the patients and healthy control groups. | ClinicalTrials.gov |
| Secondary | Ultrasound measures-MCA-PI(middle cerebral artery-pulsatility index) | baseline, 1 and 2 years after follow-up | Pulsatility index (PI) in the middle cerebral artery (MCA) is considered a measure of peripheral vascular resistance. The investigators want to explore the peripheral vascular resistance by MCA-PI. | ClinicalTrials.gov |
| Secondary | Ultrasound measures-IMT( intima-media thickness) | baseline, 1 and 2 years after follow-up | The carotid intima-media thickness (IMT) is a widely used surrogate marker for atherosclerosis worldwide. The investigators want to explore the risk of recurrence of cerebrovascular events by IMT. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 7
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Verbal Learning | Primary outcome | ConductCognition |
| Attention Network Test | Secondary outcome | ConductCognition |
| Complex Figure Copy and Recall | Secondary outcome | ConductCognition |
| Line Angle Matching | Secondary outcome | ConductCognition |
| Picture Naming Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)