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Completed

NCT Number: NCT06496347

CBB Satisfaction Survey

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.

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

For MCI/dementia groups:

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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:

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Cheng Sheng Chen

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 11, 2024
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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