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CognivAiD Real-World Evidence Clinical Registry (CONNECT Registry)

CognivAiD Real-World Evidence Clinical Registry

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06228638
Acronym
CONNECT
Enrollment
100
Registered
2024-01-29
Start date
2023-12-12
Completion date
2025-01-31
Last updated
2024-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia, Vascular, Memory Impairment

Keywords

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

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).

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.

Interventions

OTHERCognivAID (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.

Sponsors

Moleac Pte Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Safety reportingbaseline, one month, 3rd month, 6th month, 9th month and one yearThe Registry will collect adverse events or side effects reported by the doctors .

Countries

Singapore

Contacts

Primary ContactSylvain Durrleman
sylvain.durrleman@moleac.com+33 677105764
Backup ContactSherwin Joy U Agustin, MD
sherwin.agustin@moleac.com9655-55509

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026