Memory ImpairmentCONNECTNCT06228638
CognivAiD Real-World Evidence Clinical Registry (CONNECT Registry)
An observational study of Memory Impairment and Dementia, Vascular, run by Moleac Pte Ltd. at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Memory Impairment, Dementia, Vascular
- What is being tested?
- CognivAID (Sailuotong)
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- 12 Dec 2023to 31 Jan 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population would involve patients with MCI, Vascular dementia, Dementia who are taking or prescribed CognivAiD.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Raffles Hospital
Singapore, 188770
Rachel Lau, University, + 65 6311 2305, Rachel_Lau@raffles.com
Christie Yang, University, + 65 6311 2305, yang_christie@rafflesmedical.com
About this study
Official title: 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).
Read the 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.
- Conditions
- Memory Impairment, Dementia, Vascular
- Being tested
- CognivAID (Sailuotong)
- Keywords
- CognivAiD, Memory Cognitive Impairment, Vascular Dementia, Traditional Chinese Medicine
- Medical subject headings
- Memory Disorders, Dementia, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CognivAID (Sailuotong)Other
Also called 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety reporting
The Registry will collect adverse events or side effects reported by the doctors .
Measured: baseline, one month, 3rd month, 6th month, 9th month and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start12 Dec 2023
- Primary completion20 Dec 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Memory ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Moleac Pte Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Narayanaswamy U Venketasubramanian, MD, Principal investigator, Raffles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228638
- Sponsor's protocol ID
- SAFE2022_01
- Acronym
- CONNECT
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2024
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The plan is to share unidentified data with other investigators who are part of the study.
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.
PubMed 24761653Seto 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.
PubMed 28067784Zhang 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.
PubMed 31565154Steiner 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.
PubMed 26762282Chang 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.
PubMed 28115971
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CognivAiD Real-World Evidence Clinical Registry
- ClinicalTrials.gov ID
- NCT06228638
- Acronym / sponsor ID
- CONNECT / SAFE2022_01
- Conditions
- Memory Impairment, Dementia, Vascular
- Keywords
- CognivAiD, Memory Cognitive Impairment, Vascular Dementia, Traditional Chinese Medicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Moleac Pte Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population would involve patients with MCI, Vascular dementia, Dementia who are taking or prescribed CognivAiD.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CognivAID (Sailuotong)Also: SAILUOTONGCognivAiD 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. | Other | – |
Primary outcome
Safety reporting
Time frame: baseline, one month, 3rd month, 6th month, 9th month and one year
The Registry will collect adverse events or side effects reported by the doctors .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Results publication: PubMed 24761653Zhang 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.
- Results publication: PubMed 28067784Seto 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.
- Results publication: PubMed 31565154Zhang 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.
- Results publication: PubMed 26762282Steiner 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.
- Results publication: PubMed 28115971Chang 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.
- Individual participant dataSharing planned: Yes. The plan is to share unidentified data with other investigators who are part of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Narayanaswamy U Venketasubramanian, MD principal investigator
Raffles Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Memory Impairment and Dementia, Vascular, run by Moleac Pte Ltd. at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sylvain Durrleman (+33 677105764, sylvain.durrleman@moleac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety reporting (time frame: baseline, one month, 3rd month, 6th month, 9th month and one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06228638, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.