NCT01978730

Phase 2 Clinical Trial of SaiLuoTong Capsule for Vascular Dementia：A 26-week, Multicentre, Randomized, Double -Blind, Placebo-controlled Trial With a 26-week Open-label Extension

Status unknown Phase 2 Last updated 7 May 2014

What this trial tests

Phase 2 trial testing high dose group of SaiLuoTong capsule in Vascular Dementia in 372 participants. Status unknown.

Timeline

1 December 2011

Primary endpoint
1 July 2014

1 July 2014

Quick facts

Lead sponsor	Shineway Pharmaceutical Co.,Ltd
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	372
Start date	1 December 2011
Primary completion	1 July 2014
Estimated completion	1 July 2014
Sites	16 locations across China

Drugs / interventions tested

• high dose group of SaiLuoTong capsule — full drug profile →
• low dose group of SaiLuoTong — full drug profile →
• the control group — full drug profile →

Conditions studied

• Vascular Dementia — all drugs for Vascular Dementia →

Sponsor

Shineway Pharmaceutical Co.,Ltd — full company profile →

Who can join

40 and older, any sex, with Vascular Dementia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• V-ADAS-cog
  Time frame: weeks 0, 13, 26, 39, and 52
  The V-ADAS-cog comprises the ADAS-cog plus the Maze and Number Cancellation test to specifically assess executive function.
• ADCS-CGIC
  Time frame: weeks 0, 13, 26, 39, and 52
  The ADCS-CGIC involves comparison of data acquisition from both home and clinic and the use of both informant-ratings and self-ratings. Important outcomes include clinical global impressions of change (CGIC) as indicators of clinically meaningful change.

Sponsor's own description

As a traditional Chinese medicine compound, SaiLuoTong capsule is proven to have beneficial effects on learning and memory ability in animal models of vascular dementia (VaD). The study hypothesis is that SaiLuoTong capsule will be effective in the treatment of patients with VaD and will be well tolerated. The purpose of the study is to determine the efficacy and safety of SaiLuoTong capsule on patients with mild to moderate VaD. The outcome measures include general cognitive function, executive function, daily living skills, and mental behavior changes of symptoms in VaD patients.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy and safety of the compound Chinese medicine SaiLuoTong in vascular dementia: A randomized clinical trial.
   Jia J, Wei C, Chen S, Li F, et al · · 2018 · cited 30× · PMID 29955654 · DOI 10.1016/j.trci.2018.02.004
2. A review of SaiLuoTong (MLC-SLT) development in vascular cognitive impairment and dementia.
   Ampil ER, Ong PA, Krespi Y, Yang YH. · · 2024 · cited 1× · PMID 38751782 · DOI 10.3389/fphar.2024.1343820