DementiaBASICNCT04304859
Brief Assessment of Impaired Cognition
An observational study of Dementia, run by Danish Dementia Research Centre at 1 site in Denmark.
Trial summary
The aim is to develop and validate a new brief and accurate case-finding instrument for dementia and cognitive impairment - BASIC Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- BASIC
- How many people
- 428 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2018to 1 May 2019
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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.
Who may be able to join
- fluent in Danish
Who cannot join
- impaired eyesight or hearing
Trial locations and contacts
1 site in 1 country.
About this study
The aim is to develop and validate a new brief and accurate case-finding instrument for dementia and cognitive impairment - BASIC
Read the 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
- Conditions
- Dementia
- Being tested
- BASIC
- Keywords
- validation, casefinding tool
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BASICDiagnostic test
Validation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: BASIC | |
| Healthy controls | Test performed:
BASIC MMSE GDS-15 (Geriatric Depression Scale) Receives: Diagnostic Test: BASIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Assessment of Impaired Cognition (BASIC)
Dementia and cognitive impairment cutoff 20/21
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start1 May 2018
- Primary completion31 Oct 2018
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- 428 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Dementia Research Centre
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Gunhild Waldemar, Study director, Danish Dementia Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304859
- Sponsor's protocol ID
- NVD-2019-01
- Other IDs
- 1604063
- Acronym
- BASIC
- Status last verified
- Mar 2020
- First submitted
- 28 Nov 2019
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Assessment of Impaired Cognition
- ClinicalTrials.gov ID
- NCT04304859
- Acronym / sponsor ID
- BASIC / NVD-2019-01
- Conditions
- Dementia
- Keywords
- validation, casefinding tool
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 428 participants (actual)
- Lead sponsor
- Danish Dementia Research CentreResearch network
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 11 Mar 2020 (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 aim is to develop and validate a new brief and accurate case-finding instrument for dementia and cognitive impairment - BASIC
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases referred from GP | – | Diagnostic Test: BASICBASIC (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 |
| Healthy controls | – | Diagnostic Test: BASICTest performed: BASIC MMSE GDS-15 (Geriatric Depression Scale) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (1 listed)
- fluent in Danish
Key exclusion criteria (1 listed)
- impaired eyesight or hearing
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 |
|---|---|---|
| BASICValidation | Diagnostic test | Cases referred from GP, Healthy controls |
Primary outcome
Brief Assessment of Impaired Cognition (BASIC)
Time frame: through study completion, an average of 1 year
Dementia and cognitive impairment cutoff 20/21
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 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Gunhild Waldemar study director
Danish Dementia Research Centre
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 Dementia, run by Danish Dementia Research Centre at 1 site in Denmark.
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 1 inclusion and 1 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 Mar 2020. 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 Denmark. 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?
Brief Assessment of Impaired Cognition (BASIC) (time frame: through study completion, an average of 1 year). 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 Mar 2020.