NCT02426398

Brief Summary

This is a non-invasive study investigating whether EEG, which is used in routine clinical care can be useful in diagnosing dementia. Novel in house developed software will analyse EEG data for this purpose from people with Alzheimer's disease and healthy volunteers.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 24, 2015

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 3, 2024

Status Verified

January 1, 2024

Enrollment Period

9.8 years

First QC Date

April 16, 2015

Last Update Submit

January 2, 2024

Conditions

Dementia

Keywords

EEG

Outcome Measures

Primary Outcomes (1)

  • Significant spatiotemporal measurements from EEG

    EEG data analysis

    12 months

Study Arms (2)

People with Alzheimer's disease

People with Alzheimer's disease

Healthy volunteers

Healthy volunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Clinical diagnosis of possible or probable AD (according to revised diagnostic criteria (McKhann et al., 2011, Dubois et al., 2007)

You may qualify if:

  • Clinical diagnosis of possible or probable AD (according to revised diagnostic criteria (McKhann et al., 2011, Dubois et al., 2007)

You may not qualify if:

  • Significant vascular change on neuro-imaging (Fazekas grading of white matter change \>2) (Fazekas et al., 2002).
  • Clinical history of stroke, Parkinsonism, epilepsy or other neurological disorder. (e.g. severe auditory, visual, language or motor impairment)
  • Moderate to severe dementia (defined by research team but we wouldn't expect those with a mini mental state exam \[MMSE\] ≤ 18 to be able to participate)
  • Severe current mental health disorder (depression, psychosis).
  • Patients on sedating or antiepileptic medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Teaching Hospitals NHS Trust

Sheffield, S Yorks, S10 2HQ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Daniel Blackburn, MBChB, PhD

    Sheffield Teaching Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Blackburn, MBChB, PhD

CONTACT

01142222267d.blackburn@shef.ac.uk

Jodie Keyworth

CONTACT

j.keyworth@shef.ac.uk

Study Design

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

Study Record Dates

First Submitted

April 16, 2015

First Posted

April 24, 2015

Study Start

March 1, 2015

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

January 3, 2024

Record last verified: 2024-01

Locations

GB(1)