CognivAiD Real-World Evidence Clinical Registry (CONNECT Registry)

NCT06228638 | Unknown

• 1 other identifier: SAFE2022_01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Memory Impairment; Dementia, Vascular

Keywords

CognivAiD; Memory Cognitive Impairment; Vascular Dementia; Traditional Chinese Medicine

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

CognivAID (Sailuotong) OTHER

CognivAiD is 27.27 mg of panax ginseng standard extract, 27.27 mg of gingo biloba standard extract and 5.46 mg of crocus sativus standard extract which is equal to 60mg /capsule .CognivAiD is available at 60 mg /cap 2 caps twice a day.

Also known as: SAILUOTONG

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Moleac Pte Ltd.: lead

Study Sites (1)

Raffles Hospital

Singapore, 188770, Singapore

RECRUITING

Related Publications (5)

• 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.

  PMID: 24761653 RESULT

• 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.

  PMID: 28067784 RESULT

• 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.

  PMID: 31565154 RESULT

• 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.

  PMID: 26762282 RESULT

• 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.

  PMID: 28115971 RESULT

MeSH Terms

Conditions

Memory Disorders; Dementia, Vascular

Interventions

sailuotong

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Dementia; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Narayanaswamy U Venketasubramanian, MD

  Raffles Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvain Durrleman

CONTACT

+33 677105764; sylvain.durrleman@moleac.com

Sherwin Joy U Agustin, MD

CONTACT

9655-55509; sherwin.agustin@moleac.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: January 29, 2024
• Study Start: December 12, 2023
• Primary Completion: December 20, 2024
• Study Completion: January 31, 2025
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: one year

Locations

SG (1)