Clinical Trials List
2014-12-01 - 2017-07-21
Phase III
Terminated8
ICD-10E75.21
Fabry (-Anderson) disease
ICD-10E75.22
Gaucher disease
ICD-10E75.240
Niemann-Pick disease type A
ICD-10E75.241
Niemann-Pick disease type B
ICD-10E75.242
Niemann-Pick disease type C
ICD-10E75.243
Niemann-Pick disease type D
ICD-10E75.248
Other Niemann-Pick disease
ICD-10E75.249
Niemann-Pick disease, unspecified
ICD-10E75.3
Sphingolipidosis, unspecified
ICD-10E77.0
Defects in post-translational modification of lysosomal enzymes
ICD-10E77.1
Defects in glycoprotein degradation
ICD-10E77.8
Other disorders of glycoprotein metabolism
ICD-10E77.9
Disorder of glycoprotein metabolism, unspecified
ICD-9272.7
Lipidoses
A Double-Blind, Placebo Controlled, Multicenter Study to Assess the Effect of Evolocumab on Cognitive Function in Patients with Clinically Evident Cardiovascular Disease and Receiving Statin Background Lipid Lowering Therapy: A Study for Subjects Enrolled in the FOURIER (Study 20110118) Trial
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
Amgen Inc. USA
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- CHO-KAI WU Division of Cardiovascular Diseases
- - - Division of Cardiovascular Diseases
- JYH-MING JIMMY JUANG Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 蘇正煌 Division of Cardiovascular Diseases
- 郭任遠 Division of Cardiovascular Diseases
- 李應湘 Division of Cardiovascular Diseases
- 簡禎彥 Division of Cardiovascular Diseases
- 洪大川 Division of Cardiovascular Diseases
- 吳懿哲 Division of Cardiovascular Diseases
- 陳俊延 Division of Cardiovascular Diseases
- 周兆亮 Division of Cardiovascular Diseases
- 陳律安 Division of Cardiovascular Diseases
- 祁伯慶 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 陳建仁 Division of Cardiovascular Diseases
- Shyh-Ming Chen Division of Cardiovascular Diseases
- 楊正旭 Division of Cardiovascular Diseases
- 鄭正一 Division of Cardiovascular Diseases
- 洪志凌 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 陳俊吉 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 施志遠 Division of Cardiovascular Diseases
- Zhih-Cherng Chen Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Cheng-An Chiu Division of Cardiovascular Diseases
- Po-Chao Hsu Division of Cardiovascular Diseases
- 朱志生 Division of Cardiovascular Diseases
- Ye-Hsu Lu Division of Cardiovascular Diseases
- Tsung-Hsien Lin Division of Cardiovascular Diseases
- 顏學偉 Division of Cardiovascular Diseases
- Chun-Yuan Chu Division of Cardiovascular Diseases
- 溫文才 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 吳懿哲 Division of Cardiovascular Diseases
- 陳律安 Division of Cardiovascular Diseases
- 祁伯慶 Division of Cardiovascular Diseases
- 簡禎彥 Division of Cardiovascular Diseases
- 蘇正煌 Division of Cardiovascular Diseases
- 郭任遠 Division of Cardiovascular Diseases
- 李應湘 Division of Cardiovascular Diseases
- 陳俊延 Division of Cardiovascular Diseases
- 洪大川 Division of Cardiovascular Diseases
- 周兆亮 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
AMG145
Dosage Form
personal injector
Dosage
140 mg/mL
Endpoints
Mean Change From Baseline in Spatial Working Memory Strategy Index of Executive Function (6-8 Boxes) Z Score [ Time Frame: Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months). ]
Assessments were performed with the Cambridge Neuropsychological Test Automated Battery (CANTAB), a language-independent battery of computerized tests that is used to assess cognitive function.
The Spatial Working Memory (SWM) test assesses the cognitive domain of executive function (high-level thinking and decision making). Patients search for colored tokens hidden inside boxes on the screen by touching them. The critical instruction is that once a token has been found inside a box, there will never be a token hidden inside that box again, so patients must not return to a box where a token has been found.
The SWM strategy index of executive function represented the number of times a subject began a search with a different box. The Z score represents the standardized measure of how far an individual subject deviates from the study cohort average at baseline. A higher Z score reflects better performance. The mean change from baseline averaged across all the visits is reported.
Secondary Outcome Measures :
Mean Change From Baseline in Spatial Working Memory (SWM) Between-errors Z Score [ Time Frame: Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months). ]
Assessments were performed with the CANTAB, a language-independent battery of computerized tests that is used to assess cognitive function. The Spatial Working Memory (SWM) between-errors test assesses the cognitive domain of working memory (holding material in mind while that material is being actively processed). Patients search for colored tokens hidden inside boxes on the screen by touching them. The critical instruction is that once a token has been found inside a box, there will never be a token hidden inside that box again, so patients must not return to a box where a token has been found.
The SWM between-errors score is the number of times that a patient revisited a box in which a token had previously been found. The Z score represents the standardized measure of how far an individual participant deviates from the study cohort average at baseline. A higher Z score reflects better performance. The mean change from baseline averaged across all the visits is reported.
Mean Change From Baseline in Paired Associated Learning (PAL) Total Errors Adjusted Z Score [ Time Frame: Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months). ]
The CANTAB PAL test assesses visuospatial episodic memory (storing/retrieving information by associating an event with a time and place). Boxes on the screen opened up one at a time to reveal a number of patterns. Participants were asked to remember the location of each pattern. After all the boxes had been opened, each pattern was then shown in the center of the screen in a randomized order, and the patient should touch the box where they think each pattern was hidden. The PAL total errors adjusted comprised the number of errors committed by a patient plus an adjustment for the estimated number of errors the patient would have made on any stages that were not reached.
Z score represents the standardized measure of how far an individual patient deviates from the study cohort average at baseline. A higher Z score indicated better performance. The mean change from baseline averaged across all the visits is reported.
Mean Change From Baseline in Reaction Time (RTI) Median 5-choice Reaction Time Z Score [ Time Frame: Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months). ]
Assessments were performed with the CANTAB, a language-independent battery of computerized tests that is used to assess cognitive function. The Reaction Time (RTI) test assessed the cognitive domain of psychomotor speed (detecting and responding to a stimulus). Participants held down a button until a spot appeared in 1 of 5 circles on the screen. As soon as possible after the spot flashed up, the patient lifted their finger from the button and touched the circle in which the spot appeared. The RTI median 5-choice reaction time was the median duration between the onset of the stimulus and the release of the button. Z score represents the standardized measure of how far an individual participant deviates from the study cohort average at baseline. A higher Z score reflects better performance. The mean change from baseline averaged across all the visits is reported.
Inclution Criteria
Randomized into Study 20110118 (FOURIER; NCT01764633)
Exclusion Criteria
Current or known past diagnosis of dementia or mild cognitive impairment (MCI)
The Estimated Number of Participants
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Taiwan
13 participants
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Global
2000 participants
