Clinical trial NCT06228638: CognivAiD Real-World Evidence Clinical Registry (CONNECT Registry)
Official title: CognivAiD Real-World Evidence Clinical Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Memory Impairment
Dementia, Vascular
Keywords: CognivAiD
Memory Cognitive Impairment
Vascular Dementia
Traditional Chinese Medicine
Lead sponsor: Moleac Pte Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population would involve patients with MCI, Vascular dementia, Dementia who are taking or prescribed CognivAiD.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety reporting
timeFrame: baseline, one month, 3rd month, 6th month, 9th month and one year
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Raffles Hospital
Study officials:
affiliation: Raffles Hospital
name: Narayanaswamy U Venketasubramanian, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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 trial. BMC Complement Altern Med. 2016 Jan 13;16:15. doi: 10.1186/s12906-016-0989-0.
citation: 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.