NCT04304859

Brief Summary

The aim is to develop and validate a new brief and accurate case-finding instrument for dementia and cognitive impairment - BASIC

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
428

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 11, 2020

Completed
Last Updated

March 11, 2020

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

November 28, 2019

Last Update Submit

March 10, 2020

Conditions

Dementia

Keywords

validationcasefinding tool

Outcome Measures

Primary Outcomes (1)

  • Brief Assessment of Impaired Cognition (BASIC)

    Dementia and cognitive impairment cutoff 20/21

    through study completion, an average of 1 year

Study Arms (2)

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

BASICDIAGNOSTIC_TEST

Validation

Cases referred from GPHealthy controls

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • fluent in Danish

You may not qualify if:

  • impaired eyesight or hearing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DDRC

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Gunhild Waldemar

    Danish Dementia Research Centre

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2019

First Posted

March 11, 2020

Study Start

May 1, 2018

Primary Completion

October 31, 2018

Study Completion

May 1, 2019

Last Updated

March 11, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)