- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04304859
Brief Assessment of Impaired Cognition (BASIC)
March 10, 2020 updated by: Danish Dementia Research Centre
The aim is to develop and validate a new brief and accurate case-finding instrument for dementia and cognitive impairment - BASIC
Study Overview
Detailed Description
The case-finding instrument consists of four components: a. patient-directed questions, b. supermarket fluency, c. category-cued Memory Test, d. informant-directed questions.
The data collection was carried out at five outpatient memory clinics in Denmark
Study Type
Observational
Enrollment (Actual)
428
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Copenhagen, Denmark, 2100
- DDRC
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Cases: Patients referred from GP for diagnostic evaluation Controls: Participating patients' relatives and volunteers from ongoing research projects at the involved memory clinics.
Description
Inclusion Criteria:
- fluent in Danish
Exclusion Criteria:
- impaired eyesight or hearing
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cases referred from GP
BASIC (Brief Assessment of Impaired Cognition) MMSE (Mini Mental State Examination) Extensive diagnostic work-up including clinical interview, neurological and physical examination, laboratory screening tests, structural neuroimaging
|
Validation
|
Healthy controls
Test performed: BASIC MMSE GDS-15 (Geriatric Depression Scale) |
Validation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Assessment of Impaired Cognition (BASIC)
Time Frame: through study completion, an average of 1 year
|
Dementia and cognitive impairment cutoff 20/21
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Gunhild Waldemar, Danish Dementia Research Centre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2018
Primary Completion (Actual)
October 31, 2018
Study Completion (Actual)
May 1, 2019
Study Registration Dates
First Submitted
November 28, 2019
First Submitted That Met QC Criteria
March 10, 2020
First Posted (Actual)
March 11, 2020
Study Record Updates
Last Update Posted (Actual)
March 11, 2020
Last Update Submitted That Met QC Criteria
March 10, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NVD-2019-01
- 1604063 (Other Grant/Funding Number: Danish Ministry of Health)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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