Status:
UNKNOWN
The Influence of Vascular Burden, Amyloid Plaque and Tau Protein in Patients With Vascular Cognitive Impairment and Dementia With Tauopathy
Lead Sponsor:
Chang Gung Memorial Hospital
Conditions:
Vascular Cognitive Impairment, Alzheimer's Disease, Fronto-temporal Dementia
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief 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 p...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Life expectancy less than 1 year.
- Clinically significant abnormal laboratory values (such as AST/ALT \>= 3X of upper normal limits).
- Clinically significant or unstable medical or psychiatric illness.
- Epilepsy history.
- Cognitive impairment resulting from trauma or brain damage.
- Substance abuse or alcoholism in the past 3 months.
- Stroke history within the recent 3 months.
Key Trial Info
Start Date :
September 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT04309253
Start Date
September 21 2018
End Date
November 30 2025
Last Update
May 1 2023
Active Locations (1)
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1
Department of Neurology, Chang-Gung memorial Hospital
Taoyuan District, Guishan, Taiwan, 333