CognivAiD Real-World Evidence Clinical Registry (CONNECT Registry)

Memory Impairment Clinical Trial

— CONNECT  

Official title:

CognivAiD Real-World Evidence Clinical Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06228638
• Other study ID #: SAFE2022_01
• Status: Recruiting
• Start date: December 12, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: January 2024
• Source: Moleac Pte Ltd.
• Contact: Sylvain Durrleman
• Phone: +33 677105764
• Email: sylvain.durrleman[@]moleac.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 31, 2025
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dementia
• Dementia, Vascular
• Memory Impairment

Intervention

Other:
• CognivAID (Sailuotong)
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.

Locations

Country	Name	City	State
Singapore	Raffles Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Moleac Pte Ltd.

Country where clinical trial is conducted

Singapore, 

References & Publications (5)

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 De — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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 Cel — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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