Alzheimer DiseaseNCT06496347
CBB Satisfaction Survey
An observational study of Alzheimer Disease and Cognitive Impairment, run by Cheng Sheng Chen at 1 site in Taiwan.
Trial summary
The Cogstate Brief Battery (CBB) is a computerized measure for cognitive screening that consists of four cognitive tasks to assess psychomotor function, attention, learning, and working memory, and provides an easy-to-interpret report without the need for manual scoring. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Cognitive Impairment
- How many people
- 192 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 May 2022to 18 May 2023
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Two hundred seventy-one participants are planned to be recruited and it is expected to have 180 eligible participants for data analysis with 33% dropout rates estimated. The distribution of the number of participants is as follows: Participant group estimate enrolled participant no. eligible participant no. HC (healthy control) 60 40 MCI 60 40 AD 75 50 VaD 38 25 DLB 38 25
Who may be able to join
- Patient diagnosed with MCI, AD dementia, VaD or DLB
- Participant who is 50-85 years of age
- Taiwanese who had finished primary education
- Participant (or legally acceptable representative) who signed the written ICF
- Healthy volunteers without objective cognitive impairment
- Participant who is 50-85 years of age
- Taiwanese who had finished primary education
- Participant who signed the written ICF
Who cannot join
- Participant with GDS score ≥ 10
- Participant with CDR score > 1 (Assessment result within 6 months can be used conditionally.)
- Participant with MMSE score ≤ 17 (MMSE score will be converted from CASI score. Assessment result within 6 months can be used conditionally.)
- Participant diagnosed with Schizophrenia
- Participant diagnosed with Parkinson's disease
- Participant diagnosed with cancer (except basal cell skin carcinoma) in the past two years
Show all 19Show fewer
- Participant diagnosed with uncontrolled diabetes
- Participant with regular alcohol use exceeding two standard drinks per day for women or four per day for men (one standard drink corresponds to 350 cc of beer)
- Participant unable to take CBB test according to the investigator's discretion, such as blindness
- Participant who, in the opinion of the investigator or medical monitor, should not participate in the study
- For HC group:
- Participant with GDS score ≥ 10
- Participant diagnosed with Schizophrenia
- Participant diagnosed with Parkinson's disease
- Participant diagnosed with cancer (except basal cell skin carcinoma) in the past two years
- Participant diagnosed with uncontrolled diabetes
- Participant with regular alcohol use exceeding two standard drinks per day for women or four per day for men (one standard drink corresponds to 350 cc of beer)
- Participant unable to take CBB test according to the investigator's discretion, such as blindness
- Participant who, in the opinion of the investigator or medical monitor, should not participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
The Cogstate Brief Battery (CBB) is a computerized measure for cognitive screening that consists of four cognitive tasks to assess psychomotor function, attention, learning, and working memory, and provides an easy-to-interpret report without the need for manual scoring. Clinical trials and research studies have proven the validity of CBB for cognitive assessment and distinguish MCI or dementia from normal aging.
Participants express a growing acceptance of the use of computerized tests for detecting cognitive impairment, viewing it as a potential tool to improve quality of patient care and the patient-clinician relationship when used in conjunction with the "human touch." The CBB utilizes non-verbal playing-card stimuli in order to minimize language, educational and cultural biases affecting performance. It has the advantages of being portable (adaptable to notebooks, tablets, and even smart phones), short (20-30 min), game-like in presentation and thus motivating, and cross-culturally adaptable. The CBB is well liked in waiting rooms of primary care settings. It is assumed that the CBB will also be highly accepted by Taiwanese.
- Conditions
- Alzheimer Disease, Cognitive Impairment
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| healthy control (HC) group, | no intervention(s) | |
| MCI/dementia group | no intervention(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
CBB Testing Score and Brain Age Score
Participant satisfaction with using CBB will be measured by the paper-and-pencil satisfaction survey including 15 questions. See Appendix 1: Satisfaction Survey for Participant. Score of Question 2 will be ranged from "Strongly agree" (1) to "Strongly disagree" (5). Scores of Question 3~13 will be ranged from "Strongly disagree" (1) to "Strongly agree" (5).
The participant satisfaction rates will be estimated from Question 2, 3, 5, 6, 8, 9, 11, 12 and 13, and calculated in accordance with the following formula:
Satisfaction rate = (number of score 5 and 4 / number of answers) x 100% The satisfaction rate of each question mentioned above and the frequency of each score of each question will be evaluated and presented by groups of HC and MCI.
Measured: Data analysis and study report: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start9 May 2022
- Primary completion18 May 2023
- Study completion18 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cheng Sheng Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cheng Sheng Chen, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496347
- Sponsor's protocol ID
- CBB-TWSS-21
- Status last verified
- Jul 2024
- First submitted
- 25 Jun 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CBB Satisfaction Survey
- ClinicalTrials.gov ID
- NCT06496347
- Acronym / sponsor ID
- CBB-TWSS-21
- Conditions
- Alzheimer Disease, Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Cheng Sheng ChenUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 18 May 2023 (actual)
- Study completion
- 18 May 2023 (actual)
- First posted
- 11 Jul 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.
The Cogstate Brief Battery (CBB) is a computerized measure for cognitive screening that consists of four cognitive tasks to assess psychomotor function, attention, learning, and working memory, and provides an easy-to-interpret report without the need for manual scoring. Clinical trials and research studies have proven the validity of CBB for cognitive assessment and distinguish MCI or dementia from normal aging.
Participants express a growing acceptance of the use of computerized tests for detecting cognitive impairment, viewing it as a potential tool to improve quality of patient care and the patient-clinician relationship when used in conjunction with the "human touch." The CBB utilizes non-verbal playing-card stimuli in order to minimize language, educational and cultural biases affecting performance. It has the advantages of being portable (adaptable to notebooks, tablets, and even smart phones), short (20-30 min), game-like in presentation and thus motivating, and cross-culturally adaptable. The CBB is well liked in waiting rooms of primary care settings. It is assumed that the CBB will also be highly accepted by Taiwanese.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy control (HC) group, | – | –no intervention(s) |
| MCI/dementia group | – | –no intervention(s) |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Two hundred seventy-one participants are planned to be recruited and it is expected to have 180 eligible participants for data analysis with 33% dropout rates estimated. The distribution of the number of participants is as follows: Participant group estimate enrolled participant no. eligible participant no. HC (healthy control) 60 40 MCI 60 40 AD 75 50 VaD 38 25 DLB 38 25
Key inclusion criteria (8 listed)
- Patient diagnosed with MCI, AD dementia, VaD or DLB
- Participant who is 50-85 years of age
- Taiwanese who had finished primary education
- Participant (or legally acceptable representative) who signed the written ICF
- Healthy volunteers without objective cognitive impairment
Key exclusion criteria (19 listed)
- Participant with GDS score ≥ 10
- Participant with CDR score > 1 (Assessment result within 6 months can be used conditionally.)
- Participant with MMSE score ≤ 17 (MMSE score will be converted from CASI score. Assessment result within 6 months can be used conditionally.)
- Participant diagnosed with Schizophrenia
- Participant diagnosed with Parkinson's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CBB Testing Score and Brain Age Score
Time frame: Data analysis and study report: 3 months
Participant satisfaction with using CBB will be measured by the paper-and-pencil satisfaction survey including 15 questions. See Appendix 1: Satisfaction Survey for Participant. Score of Question 2 will be ranged from "Strongly agree" (1) to "Strongly disagree" (5). Scores of Question 3~13 will be ranged from "Strongly disagree" (1) to "Strongly agree" (5). The participant satisfaction rates will be estimated from Question 2, 3, 5, 6, 8, 9, 11, 12 and 13, and calculated in accordance with the following formula: Satisfaction rate = (number of score 5 and 4 / number of answers) x 100% The satisfaction rate of each question mentioned above and the frequency of each score of each question will be evaluated and presented by groups of HC and MCI.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Alzheimer Disease and Cognitive Impairment, run by Cheng Sheng Chen at 1 site in Taiwan.
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 19 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: finished, as of the sponsor's last update on 11 Jul 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CBB Testing Score and Brain Age Score (time frame: Data analysis and study report: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2024.