CognivAiD Real-World Evidence Clinical Registry (CONNECT Registry) (CONNECT)

CognivAiD Real-World Evidence Clinical Registry

This is an observational, prospective cohort of patients who were prescribed or have taken CognivAiD as prescribed by the attending physician. The safety and efficacy of CognivAiD have been established in clinical studies. The registry will assess the safe use and effectiveness of CognivAiD in a real-world setting. The registry is designed as a product registry in clinical practice. The design also takes into account the different scenarios of product use in the real world (e.g., switching therapies during follow-up, use of multiple products in combination or sequence, different dosing, and compliance).

Study Overview

• Status: Recruiting
• Conditions: Dementia, Vascular; Memory Impairment
• Intervention / Treatment: Other: CognivAID (Sailuotong)

Detailed Description

While the safety and efficacy of CognivAiD is established in clinical studies, this registry will assess the safe use and effectiveness of CognivAiD in the real-world setting. The design also takes into account the different scenarios of product use in the real world (e.g., switching therapies duObjectivesThe primary objective of this registry is to evaluate the use, safety, and effectiveness of CognivAiD This project is not a clinical trial wherein an active intervention intended to change human subject's outcome is implemented and takes decision-making away from the physician and patient. This registry uses an observational study design that does not specify or assign treatments or therapies. The registry is designed by keeping as closely as possible to real-world practice and as unobtrusive as possible to closely reflect usual practice and normal standards of care.

There are few inclusion and exclusion criteria to include a broad range of participants to make the results more generalizable. Participants are observed as they present for care and the data collected reflects existing tests, measurements, and treatments a healthcare provider customarily uses. Participation in the registry is entirely voluntary.

The primary objective of the registry is to evaluate the use, safety, and effectiveness of CognivAiD in a real-world setting. The primary data elements include the reporting of side effects and adverse events. Data collection and includes demographics, education, number of years, past medical history, CognivAiD information and, neurological status by the standard clinical practice and normal standard of care. Cognitive Assessment will be performed as per routine clinical visit. Collected data will be entered into the online study database.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Sylvain Durrleman; Phone Number: +33 677105764; Email: sylvain.durrleman@moleac.com
• Study Contact Backup: Name: Sherwin Joy U Agustin, MD; Phone Number: 183 9655-55509; Email: sherwin.agustin@moleac.com

Study Locations

• Singapore
  • Singapore, Singapore, 188770
    • Recruiting
    • Raffles Hospital
    • Contact: Rachel Lau, University; Phone Number: + 65 6311 2305; Email: Rachel_Lau@raffles.com
    • Contact: Christie Yang, University; Phone Number: + 65 6311 2305; Email: yang_christie@rafflesmedical.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The population would involve patients with MCI, Vascular dementia, Dementia who are taking or prescribed CognivAiD.

Description

Inclusion Criteria:

• Male or female
• Legal age as per country requirement
• Already taking or having to receive a prescription for CognivAiD (decision must have been made before consideration to participate in the registry)
• Agrees to be included in the registry, provides written consent inclusion criteria
• Male or female
• Legal age as per country requirement
• Already taking or having to receive a prescription for CognivAiD (decision must have been made before consideration to participate in the registry)
• Agrees to be included in the registry, provides written consent, and allows retrieval and analysis of data by local requirements.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety reporting	The Registry will collect adverse events or side effects reported by the doctors .	baseline, one month, 3rd month, 6th month, 9th month and one year

Collaborators and Investigators

• Sponsor: Moleac Pte Ltd.
• Investigators: Principal Investigator: Narayanaswamy U Venketasubramanian, MD, Raffles Hospital

Publications and helpful links

General Publications

• Zhang Y, Lin L, Liu GY, Liu JX, Li T. [Pharmacokinetics and brain distribution of ginsenosides after administration of sailuotong]. Zhongguo Zhong Yao Za Zhi. 2014 Jan;39(2):316-21. Chinese.
• Seto SW, Chang D, Ko WM, Zhou X, Kiat H, Bensoussan A, Lee SM, Hoi MP, Steiner GZ, Liu J. Sailuotong Prevents Hydrogen Peroxide (H(2)O(2))-Induced Injury in EA.hy926 Cells. Int J Mol Sci. 2017 Jan 5;18(1):95. doi: 10.3390/ijms18010095.
• Zhang Y, Liu J, Yao M, Song W, Zheng Y, Xu L, Sun M, Yang B, Bensoussan A, Chang D, Li H. Sailuotong Capsule Prevents the Cerebral Ischaemia-Induced Neuroinflammation and Impairment of Recognition Memory through Inhibition of LCN2 Expression. Oxid Med Cell Longev. 2019 Sep 3;2019:8416105. doi: 10.1155/2019/8416105. eCollection 2019.
• Steiner GZ, Yeung A, Liu JX, Camfield DA, Blasio FM, Pipingas A, Scholey AB, Stough C, Chang DH. The effect of Sailuotong (SLT) on neurocognitive and cardiovascular function in healthy adults: a randomised, double-blind, placebo controlled crossover pilot trial. BMC Complement Altern Med. 2016 Jan 13;16:15. doi: 10.1186/s12906-016-0989-0.
• Chang D, Liu J, Bilinski K, Xu L, Steiner GZ, Seto SW, Bensoussan A. Herbal Medicine for the Treatment of Vascular Dementia: An Overview of Scientific Evidence. Evid Based Complement Alternat Med. 2016;2016:7293626. doi: 10.1155/2016/7293626. Epub 2016 Dec 27.

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2023
• Primary Completion (Estimated): December 20, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: January 15, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Traditional Chinese Medicine; Vascular Dementia; CognivAiD; Memory Cognitive Impairment
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neurocognitive Disorders; Intracranial Arterial Diseases; Intracranial Arteriosclerosis; Leukoencephalopathies; Dementia; Dementia, Vascular
• Other Study ID Numbers: SAFE2022_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The plan is to share unidentified data with other investigators who are part of the study.
• IPD Sharing Time Frame: one year
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No