Vascular Cognitive Impairment Clinical Trial
Official title:
Study on Early Brain Injury Mechanism and Comprehensive Intervention of Vascular Cognitive Impairment
Alzheimer's disease (AD) and vascular dementia (VaD) are the most common forms of senile dementia. Although the animal research of dementia has made remarkable progress, clinical trials of drugs for AD pathology have failed in recent years. The study of dementia based on cell and animal model generally aims at a single mechanism and target, and its results are quite different from the real clinical environment. More and more studies suggest that investigators should shift the focus of research to the early stage of cognitive impairment before dementia. Prevention is more important than cure, and intervention against multi-factors and multi-targets has become an important consensus. A large number of studies have shown that the mechanism of vascular brain injury plays an important role in the pathogenesis of AD and VaD, and many vascular risk factors are interventionable to some extent. Therefore, based on the clinical cohort, in-depth study of vascular cognitive impairment (Vascular cognitive impairment, VCI) has important clinical significance for the effective prevention and treatment of AD and VaD. The leading team of the project has focused on VCI research for a long time. After nearly 20 years of experimental research and preliminary clinical observation, it is proposed that chronic cerebral ischemia can not only be a clinical disease entity, but also an important pathological basis for the early onset of VCI. This view has recently been supported by a number of authoritative international research evidence. Big data's study of 1171 patients with AD reported by Nature Commun in 2016 shows that the early pathological changes of AD may not be a cascade of amyloid protein (Aβ), but a decrease in cerebral blood flow. Therefore, this project intends to establish an early clinical research cohort of VCI to focus on three key issues in VCI research and clinical practice: (1) the theory that cerebral hypoperfusion may be an important pathological basis for the occurrence and development of VCI needs direct evidence support from clinical studies, and its mechanism needs further elucidation. (2) Based on the fusion of multimodal MRI of VCI vascular brain injury pathology and PET imaging markers of Aβ molecular pathology, a multivariate VCI cognitive evaluation model is constructed, and its sensitivity and specificity may be better than the existing VCI diagnostic standards. (3) the protective effect of early comprehensive intervention of vascular risk factors on cognitive decline in VCI may be more effective than that of single risk factor. The first part of this project is to establish a study cohort of non-demented vascular cognitive impairment(VCIND). Neurocognitive function assessment combined with multimodal MRI including ASL, DCE, DTI and BOLD techniques were used to observe the role of cerebral hypoperfusion in the early stage and progression of VCI. At the same time, the relationship between the changes of blood-brain barrier and neural network and cognitive decline was dynamically observed to verify and explore the effect and mechanism of cognitive impairment caused by cerebral hypoperfusion. The second part studies the pathology of vascular brain injury based on MRI and the molecular pathology of A β based on PET and the relationship between Aβ molecular pathology and cognitive impairment, including the main factors affecting cognitive function, and uses artificial intelligence (AI) algorithm to develop a multiple quantitative evaluation system of VCI cognitive function, which is mainly based on the fusion of MRI and PET image markers. In the third part, a multicenter randomized controlled clinical cohort study was conducted to observe the cognitive protective effect of comprehensive intensive intervention of vascular risk factors on early VCI, so as to provide direct clinical evidence and intervention model for the prevention and treatment of VCI. The topics of the above three aspects covered by this project are closely related, which is not only a key scientific problem, but also an important clinical problem to be solved in the diagnosis and treatment of VCI. The study of this project is expected to further clarify the role and mechanism of cerebral hypoperfusion in VCI, provide a new theoretical basis for the prevention and treatment of dementia, and develop a quantitative evaluation system of VCI cognitive function mainly based on imaging technology and AI algorithm, so as to provide a more accurate and convenient diagnostic tool for early clinical identification and scientific research of VCI. Draw up the early comprehensive intervention paradigm of VCI based on vascular risk factors and popularize it in clinic, gradually form an expert consensus, enrich and update the guidelines for diagnosis and treatment of dementia, and effectively improve the level of prevention and treatment of dementia related to VCI.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | December 2023 |
Est. primary completion date | November 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 75 Years |
Eligibility | Inclusion Criteria: - ?Healthy volunteers or VCIND patients(Diagnostic criteria comply with the "Guidelines for the Diagnosis and Treatment of Vascular Cognitive Impairment" formulated by the Dementia and Cognitive Impairment Group of the Neurology Branch of the Chinese Medical Association); - ?Age between 50-70 years old; - ?Able to accept and cooperate in completing various instrumental examinations and neuropsychological examinations Scale testing; - ?Agree to sign an informed consent form. Exclusion Criteria: - ?Combined with other serious diseases, life expectancy is less than 3 years; - ?Patients with vision and hearing impairment that significantly affect cognitive testing; - ?Severe heart, brain, lung, kidney and other diseases; - ?Have a history of psychoactive substance abuse; - ?Have other serious physical diseases that affect cognitive testing, such as coma, epilepsy, hypothyroidism , Hypoxemia, etc.; - ?have a history of mental illness; - ?have MRI contraindications, unwilling to participate in research and unconditional follow-up. |
Country | Name | City | State |
---|---|---|---|
China | Zhongnan Hospital | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Zhongnan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Montreal Cognitive Assessment (MoCA) | The scores of the MoCA tests are used to evaluate the cognitive function of the subjects. MoCA is a brief, 30-question test that helps healthcare professionals detect cognitive impairments very early on, allowing for faster diagnosis and patient care. MoCA is the most sensitive test available for measuring multiple cognitive domains which are important components not measured by the MMSE.
The minimum value of Montreal Cognitive Assessment measurement is 0 and the maximum value is 30. Overall, a worse Moca score represents a worse cognitive function of the participants. |
Baseline | |
Primary | Montreal Cognitive Assessment (MoCA) | The scores of the MoCA tests are used to evaluate the cognitive function of the subjects. MoCA is a brief, 30-question test that helps healthcare professionals detect cognitive impairments very early on, allowing for faster diagnosis and patient care. MoCA is the most sensitive test available for measuring multiple cognitive domains which are important components not measured by the MMSE.
The minimum value of Montreal Cognitive Assessment measurement is 0 and the maximum value is 30. Overall, a worse Moca score represents a worse cognitive function of the participants. |
One-year follow-up | |
Primary | Montreal Cognitive Assessment (MoCA) | The scores of the MoCA tests are used to evaluate the cognitive function of the subjects. MoCA is a brief, 30-question test that helps healthcare professionals detect cognitive impairments very early on, allowing for faster diagnosis and patient care. MoCA is the most sensitive test available for measuring multiple cognitive domains which are important components not measured by the MMSE.
The minimum value of Moca measurement is 0 and the maximum value is 30. Overall, a worse Montreal Cognitive Assessment score represents a worse cognitive function of the participants. |
Two-year follow-up | |
Primary | Montreal Cognitive Assessment (MoCA) | The scores of the MoCA tests are used to evaluate the cognitive function of the subjects. MoCA is a brief, 30-question test that helps healthcare professionals detect cognitive impairments very early on, allowing for faster diagnosis and patient care. MoCA is the most sensitive test available for measuring multiple cognitive domains which are important components not measured by the MMSE.
The minimum value of Montreal Cognitive Assessment measurement is 0 and the maximum value is 30. Overall, a worse Moca score represents a worse cognitive function of the participants. |
Three-year follow-up | |
Primary | Mini-Mental State Examination(MMSE) | MMSE is used as a screening scale for cognitive impairment, can measure the participants' global cognitive function.
The minimum value of the Mini-Mental State Examination measurement value is 0 and the maximum value is 30. A worse MMSE score represents a worse cognitive function of the participants. |
Baseline | |
Primary | Mini-Mental State Examination(MMSE) | MMSE is used as a screening scale for cognitive impairment, can measure the participants' global cognitive function.
The minimum value of the Mini-Mental State Examination measurement value is 0 and the maximum value is 30. A worse MMSE score represents a worse cognitive function of the participants. |
One-year follow-up | |
Primary | Mini-Mental State Examination(MMSE) | MMSE is used as a screening scale for cognitive impairment, can measure the participants' global cognitive function.
The minimum value of the Mini-Mental State Examination measurement value is 0 and the maximum value is 30. A worse MMSE score represents a worse cognitive function of the participants. |
Two-year follow-up | |
Primary | Mini-Mental State Examination(MMSE) | MMSE is used as a screening scale for cognitive impairment, can measure the participants' global cognitive function.
The minimum value of the Mini-Mental State Examination measurement value is 0 and the maximum value is 30. A worse MMSE score represents a worse cognitive function of the participants. |
Three-year follow-up | |
Secondary | Auditory Verbal Learning Test(AVLT) | AVLT is used to measure participantins' instantaneous memory and delayed recall.
The minimum value of the Auditory Verbal Learning Test score is 0, and the maximum value is 12 (delayed recall) or 36 ( instantaneous memory). A higher score means better cognitive function. |
Baseline | |
Secondary | Auditory Verbal Learning Test(AVLT) | AVLT is used to measure participantins' instantaneous memory and delayed recall.
The minimum value of the Auditory Verbal Learning Test score is 0, and the maximum value is 12 (delayed recall) or 36 ( instantaneous memory). A higher score means better cognitive function. |
One-year follow-up | |
Secondary | Auditory Verbal Learning Test(AVLT) | AVLT is used to measure participantins' instantaneous memory and delayed recall.
The minimum value of the Auditory Verbal Learning Test score is 0, and the maximum value is 12 (delayed recall) or 36 ( instantaneous memory). A higher score means better cognitive function. |
Two-year follow-up | |
Secondary | Auditory Verbal Learning Test(AVLT) | AVLT is used to measure participantins' instantaneous memory and delayed recall.
The minimum value of the Auditory Verbal Learning Test score is 0, and the maximum value is 12 (delayed recall) or 36 ( instantaneous memory). A higher score means better cognitive function. |
Three-year follow-up | |
Secondary | Verbal Fluency Test (VFT) | Verbal fluency test is used to measure language ability. The minimum value of the Verbal Fluency Test score is 0. A higher score represents a better language function. | Baseline | |
Secondary | Verbal Fluency Test (VFT) | Verbal fluency test is used to measure language ability. The minimum value of the Verbal Fluency Test score is 0. A higher score represents a better language function. | One-year follow-up | |
Secondary | Verbal Fluency Test (VFT) | Verbal fluency test is used to measure language ability. The minimum value of the Verbal Fluency Test score is 0. A higher score represents a better language function. | Two-year follow-up | |
Secondary | Verbal Fluency Test (VFT) | Verbal fluency test is used to measure language ability. The minimum value of the Verbal Fluency Test score is 0. A higher score represents a better language function. | Three-year follow-up | |
Secondary | Clock Drawing Test(CDT) | CDT is used to measure visual space ability. The minimum value of the Clock Drawing Test score is 0 and the maximum value is 15. A test score lower than 12 means that the participant's visual space function is impaired. | Baseline | |
Secondary | Clock Drawing Test(CDT) | CDT is used to measure visual space ability. The minimum value of the Clock Drawing Test score is 0 and the maximum value is 15. A test score lower than 12 means that the participant's visual space function is impaired. | One-year follow-up | |
Secondary | Clock Drawing Test(CDT) | CDT is used to measure visual space ability. The minimum value of the Clock Drawing Test score is 0 and the maximum value is 15. A test score lower than 12 means that the participant's visual space function is impaired. | Two-year follow-up | |
Secondary | Clock Drawing Test(CDT) | CDT is used to measure visual space ability. The minimum value of the Clock Drawing Test score is 0 and the maximum value is 15. A test score lower than 12 means that the participant's visual space function is impaired. | Three-year follow-up | |
Secondary | Trail Making Test(TMT) | The Trail Making Test is used as an indicator of visual scanning, graphomotor speed, and executive function.
The time taken by the participants to complete the Trail Making Test and the number of errors during the test need to be recorded. The longer the participants spend, the more errors they make, and the worse their executive function is. |
Baseline | |
Secondary | Trail Making Test(TMT) | The Trail Making Test is used as an indicator of visual scanning, graphomotor speed, and executive function.
The time taken by the participants to complete the Trail Making Test and the number of errors during the test need to be recorded. The longer the participants spend, the more errors they make, and the worse their executive function is. |
One-year follow-up | |
Secondary | Trail Making Test(TMT) | The Trail Making Test is used as an indicator of visual scanning, graphomotor speed, and executive function.
The time taken by the participants to complete the Trail Making Test and the number of errors during the test need to be recorded. The longer the participants spend, the more errors they make, and the worse their executive function is. |
Two-year follow-up | |
Secondary | Trail Making Test(TMT) | The Trail Making Test is used as an indicator of visual scanning, graphomotor speed, and executive function.
The time taken by the participants to complete the Trail Making Test and the number of errors during the test need to be recorded. The longer the participants spend, the more errors they make, and the worse their executive function is. |
Three-year follow-up |
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