The Influence of Vascular Burden, Amyloid Plaque and Tau Protein in Patients With Vascular Cognitive Impairment and Dementia With Tauopathy

Who is this study for? Adult patients with Vascular Cognitive Impairment and Alzheimer's Disease
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Background and objects Amyloid plaques and tau protein are the landmarks of neurodegeneration in Alzheimer's disease (AD). On the other hand, it is reported that cerebral ischemia may induce amyloid plaques and tau protein accumulation. However, it was difficult to in vivo disentangle the complex and dynamic interactions between AD pathophysiology and cerebral vascular injury during the post-stroke cognitive impairment development in the past. With the advent of novel radiotracers specific to cerebral amyloid plaques and tau protein, we aim to conduct a prospective multimodal neuroimaging cohort study to investigate the contribution of vascular injury, amyloid plaque and tau protein to cognitive impairment. Subjects and methods The prospective project plans to recruit patients with vascular cognitive impairment (VCI) (Group A, n=80), Alzheimer's disease/mild cognitive impairment (MCI) (Group B, n = 120), fronto-temporal dementia (FTD) (Group C, n =30), and progressive supranuclear palsy (PSP) (Group E, n = 80). In addition, another 30 healthy people will be recruited as the control group (Group D, n=30). \[18F\]AV45 and \[18F\]MNI-958(PMPBB3) PET will be done for imaging cerebral amyloid plaque and tau protein distribution, brain MRI for obtaining structural and functional information, and neuropsychological tests for cognitive performance. Cognitive evaluation will be repeated 18 months after recruitment. In addition, APOE genotyping will be performed as well. By obtaining the neuroimaging information, such as severity of white matter change and infarction, cortical and hippocampal atrophy, and SUVRs of \[18F\]AV-45 and \[18F\]MNI-958(PMPBB3) PET, the study will be able to investigate the composite influence of cerebrovascular disease and neurodegenerative pathology on the trajectory of cognitive impairment. Group comparisons will be performed using the Chi-square test, independent t test, Mann-Whitney U test, ANOVA test, and multiple linear regression, where appropriate. Anticipation In this project, we will be able to explore the distribution patterns of amyloid plaque and tau protein among dementia patients with different etiologies, and also evaluate their influence on cognition

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: t
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• Inclusion criteria for VCI (Group A, n=80)

‣ Males or females with age \>= 20 years old.

⁃ Patients fulfill the AHA/ASA criteria for vascular cognitive impairment.

⁃ Provision of signed informed consent from the subject and the subject's legally authorized representative or caregiver (if applicable).

⁃ The subject has an appropriate caregiver capable of accompanying the subject, if necessary.

• Inclusion criteria for AD / MCI (Group B, n=120)

‣ Males or females with age \>= 20 years old.

⁃ Patients fulfill the National Institute on Aging (NIA) - Alzheimer's Association Diagnostic Guidelines.

⁃ Provision of signed informed consent from the subject and the subject's legally authorized representative or caregiver (if applicable).

⁃ The subject has an appropriate caregiver capable of accompanying the subject, if necessary.

• Inclusion criteria for FTD (Group C, n=30)

‣ Males or females with age \>= 20 years old.

⁃ Patients fulfill the criteria of probable FTD.

⁃ Provision of signed informed consent from the subject and the subject's legally authorized representative or caregiver (if applicable).

⁃ The subject has an appropriate caregiver capable of accompanying the subject, if necessary.

• Inclusion criteria for normal control (Group D, n=30)

‣ Males or females with age \>= 20 years old.

⁃ Provision of signed informed consent.

• Inclusion criteria for PSP (Group E, n=80)

‣ Males or females with age \>= 20 years old

⁃ Patients fulfill the 2017 Movement Disorder Society criteria of PSP.

⁃ Provision of signed informed consent from the subject and the subject's legally authorized representative or caregiver (if applicable)

⁃ The subject has an appropriate caregiver capable of accompanying the subject, if necessary.

Locations
Other Locations
Taiwan
Department of Neurology, Chang-Gung memorial Hospital
RECRUITING
Taoyuan District
Contact Information
Primary
Huang Kuo-Lun, M.D.
drkuolun@cgmh.org.tw
+886-3-3281200
Backup
Chen Jing-Fang
tp6tp6fg@gmail.com
+886-3-3281200
Time Frame
Start Date: 2018-09-21
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 220
Treatments
Other: PMPBB3
1. Primary endpoint(s):~ A. To determine the distribution patterns of cerebral amyloid plaques and Tau protein among AD/MCI, VCI and FTP patients as well as normal controls.~2. Secondary endpoints:~A. To correlate vascular burden, \[18F\]AV45 and \[18F\]MNI-958(PMPBB3) retention with clinical presentation and cognitive performance among different groups of subjects B. To determine the impacts of vascular burden, \[18F\]AV45 and \[18F\]MNI-958(PMPBB3) retention changes on cognitive trajectory over the 18-month follow-up period.
Other: AV45
1. Primary endpoint(s):~ A. To determine the distribution patterns of cerebral amyloid plaques and Tau protein among AD/MCI, VCI and FTP patients as well as normal controls.~2. Secondary endpoints:~A. To correlate vascular burden, \[18F\]AV45 and \[18F\]MNI-958(PMPBB3) retention with clinical presentation and cognitive performance among different groups of subjects B. To determine the impacts of vascular burden, \[18F\]AV45 and \[18F\]MNI-958(PMPBB3) retention changes on cognitive trajectory over the 18-month follow-up period.
Sponsors
Leads: Chang Gung Memorial Hospital

This content was sourced from clinicaltrials.gov