Brief Assessment of Impaired Cognition | NCT04304859

Studies
Brief Assessment of Impaired Cognition

NCT04304859

Sponsor

Danish Dementia Research Centre

Status

Completed

Last Update Posted

Mar 11, 2020Actual

Enrollment

428Actual

Phase

Not provided

Conditions

Dementia

Interventions

BASIC

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1604063	Other Grant/Funding Number	Danish Ministry of Health

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2018Actual

Primary Completion Date

Oct 31, 2018Actual

Completion Date

May 1, 2019Actual

First Submitted Date

Nov 28, 2019

First Submission Date that Met QC Criteria

Mar 10, 2020

First Posted Date

Mar 11, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2020

Last Update Posted Date

Mar 11, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

428Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Diagnostic Test: BASIC
Healthy controls		Test performed: BASIC MMSE GDS-15 (Geriatric Depression Scale)	Diagnostic Test: BASIC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BASIC	Diagnostic Test	Validation	Cases referred from GP Healthy controls

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Brief Assessment of Impaired Cognition (BASIC)	Dementia and cognitive impairment cutoff 20/21	through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

fluent in Danish

Exclusion Criteria:

impaired eyesight or hearing

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gunhild Waldemar	Danish Dementia Research Centre	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
DDRC		Copenhagen		2100	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003704	Dementia

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D019965	Neurocognitive Disorders

Browse Leaves

Not provided

Browse Branches

Not provided