Vascular Dementia Clinical Trial
Official title:
A Randomized, Double-Blind, Double-Dummy, Active-Controlled, Parallel, Comparative, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of STA-1 Capsule in Patients With Vascular Dementia (Marrow-Sea Deficiency)
The objectives of this phase II study of STA-1 capsule was to make preliminary evaluation on clinical efficacy and safety of STA-1 capsule in order that based on the dosage and study structure planned in this project, the dosage and study structure of phase III study can be confirmed.
This phase II clinical trial was planned to be in double-blind, double-dummy,
active-controlled, parallel, comparative, multicenter design. Two hundred and 40 eligible
subjects were planned to be recruited by 5 study centers. The treatment period planned in
the protocol was 3 months with 5 study visits including Randomization visit (Day 0), three
post-treatment visits (1 and 2 months after Randomization visit and Final visit) and 1
follow-up visit made at 6 month after Randomization visit.
After subjects recruited by this study having read and singed the ICF, they were arranged to
be collected information of demographics, medical history, allergy history, medication
history, and concomitant medication. Laboratory and physical examination including vital
signs were performed, and Hachinski Ischemia Score (HIS), Mini-Mental Status Examination
(MMSE), and Classification of Marrow-Sea deficiency were evaluated to ensure subject's
eligibility to enter this study. After the subjects were confirmed eligible, they were
randomly assigned to either STA-1 or Ergoloid Mesylates group. Blessed-Roth Behavior Scale
(BBS) and Activities of Daily Living (ADL) Scale were measured after subjects were
randomized. These subjects were then dispensed study medications for 1-month use.
The eligible subjects were requested to bring back unused study medication, if any, to study
centers at 1, 2, and 3 months (Final visit) after the Randomization visit. At these visits,
measurements of MMSE, BBS, ADL scales, and Classification of Marrow-Sea deficiency were
collected. Information concomitant medications and AEs were also recorded. Physical and
laboratory examinations were performed at Final visit. Each subject was dispensed with study
medications for his/her subsequent treatment period at month-1 and -2 visits. Unused study
medications were collected with drug accountability documented. Subjects were dismissed from
the study at the Final visit.
Subjects were measured MMSE, BBS, and ADL scales at 6 months after the Randomization visit
if they were available for follow-up evaluations.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04567745 -
Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers
|
Phase 1 | |
Recruiting |
NCT04109963 -
Trial of Remote Ischemic Pre-conditioning in Vascular Cognitive Impairment
|
Phase 2 | |
Recruiting |
NCT04335994 -
ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing
|
N/A | |
Not yet recruiting |
NCT06416371 -
Retinal Vessel Leakage in Cerebral Small Vessel Disease
|
||
Completed |
NCT01761227 -
Efficacy and Safety of Fufangdanshen Tablets in Mild to Moderate Vascular Dementia
|
Phase 2 | |
Active, not recruiting |
NCT01208675 -
The Swedish BioFINDER Study
|
||
Completed |
NCT00165763 -
Efficacy and Safety of Donepezil Hydrochloride (Aricept) in Vascular Dementia
|
Phase 4 | |
Completed |
NCT00621647 -
Seroquel- Agitation Associated With Dementia
|
Phase 3 | |
Recruiting |
NCT04095962 -
Effects of a Multicomponent Exercise Intervention on Physical and Cognitive Function of Older Adults With Dementia
|
N/A | |
Recruiting |
NCT03275363 -
The University of Hong Kong Neurocognitive Disorder Cohort
|
N/A | |
Active, not recruiting |
NCT03804229 -
Efficacy and Safety of Butylphthalide Soft Capsule for the Treatment of Vascular Dementia
|
Phase 3 | |
Enrolling by invitation |
NCT03724136 -
Alzheimer's Autism and Cognitive Impairment Stem Cell Treatment Study
|
N/A | |
Completed |
NCT02453932 -
Efficacy and Safety of Tianzhi Granule in Mild to Moderate Vascular Dementia
|
Phase 3 | |
Completed |
NCT00947531 -
A Clinical Trial to Evaluate the Safety and Efficacy of 20 ml Cerebrolysin in Patients With Vascular Dementia
|
Phase 4 | |
Not yet recruiting |
NCT03702543 -
Managing Vascular Dementia Risk Factors With SymTrend
|
Phase 1 | |
Enrolling by invitation |
NCT02147652 -
Personalized Music Therapy and Agitation in Dementia
|
N/A | |
Recruiting |
NCT04114994 -
Longitudinal Cognitive Assessment by BoCA
|
||
Recruiting |
NCT06034509 -
Cognitive and Vascular Functioning Following TBI
|
||
Recruiting |
NCT05921266 -
Urolithin A Supplementation in Middle-aged Adults With Obesity
|
N/A | |
Not yet recruiting |
NCT01466543 -
Effect of Zydena (Udenafil) on Cerebral Blood Flow and Peripheral Blood Viscosity
|
Phase 2 |