Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000285651
Ethics application status
Approved
Date submitted
6/03/2023
Date registered
16/03/2023
Date last updated
31/08/2023
Date data sharing statement initially provided
16/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Quantifying stimulus evoked electroencephalographic variability in mild dementia
Scientific title
A pilot study designed to compare differences in stimulus evoked electroencephalographic variability between participants assessed to be cognitively normal and participants diagnosed with mild dementia
Secondary ID [1] 309135 0
Nil known
Universal Trial Number (UTN)
U1111-1289-3730
Trial acronym
EEGVID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 329233 0
Alzheimer's Disease 329234 0
Condition category
Condition code
Neurological 326187 326187 0 0
Dementias
Neurological 326188 326188 0 0
Alzheimer's disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Twenty four participants diagnosed with mild dementia due to possible or probable Alzheimer's disease (MDAD), and 24 age matched controls (CN), will be recruited through a Cognitive Dementia and Memory Service (CADMS) Clinic.

All participants will have their time locked, 64 channel electroencephalogram (EEG), recorded in response to three simple cognitive tasks delivered by a laptop computer connected to headphones: an active visual semantic priming task, a passive visual memory repetition priming task and an active three level auditory oddball task. The active visual semantic priming task requires participants to indicate via button press whether a sequential pair of briefly presented images are semantically related. The passive visual memory repetition task involves the participant viewing a sequence of images that may be novel or repeated once or twice. The active three level auditory oddball task requires participants to listen to a sequence of randomly presented tones (drawn from one of three frequencies) and to indicate via button press when a defined target tone is heard.

EEG recordings will be performed by trained research staff. Tasks will be run consecutively in random order, with 2 minutes each of eyes-closed and eyes-open resting EEG recorded at the beginning of the testing session. The total testing time will be approximately 60 minutes.
Intervention code [1] 325582 0
Diagnosis / Prognosis
Intervention code [2] 325583 0
Early Detection / Screening
Comparator / control treatment
24 participants clinically assessed by a Neuropsychiatrist to be cognitively normal (CN group)
Control group
Active

Outcomes
Primary outcome [1] 334065 0
Time course of time locked changes in evoked EEG variability during the visual semantic priming task
Timepoint [1] 334065 0
During the single EEG recording session
Primary outcome [2] 334125 0
Time course of time locked changes in evoked EEG variability during the passive visual memory repetition priming task
Timepoint [2] 334125 0
During the single EEG recording session
Primary outcome [3] 334126 0
Time course of time locked changes in evoked EEG variability during the active three level auditory oddball task
Timepoint [3] 334126 0
During the single EEG recording session
Secondary outcome [1] 419261 0
Eyes-open resting state EEG band powers
Timepoint [1] 419261 0
During the single EEG recording session
Secondary outcome [2] 419430 0
Eyes-closed resting state EEG band powers
Timepoint [2] 419430 0
During the single EEG recording session

Eligibility
Key inclusion criteria
Male and female participants 60 years or older

English speaking and basic levels of literacy in order to be able to give informed consent and to follow all instructions

Normal or corrected hearing and vision

CN group: Formally assessed to be cognitively normal by CADMS Neuropsychiatrist

MDAD group: Formal diagnosis by CADMS Neuropsychiatrist of possible or probable Alzheimer's Disease; Mild dementia as defined by Clinical Dementia Rating score of 0.5 - 1, Global Deterioration Scale score of 4, and Min-mental Status Examination score of 18 - 23
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Colour blindness

Any history of illness affecting cognitive function e.g., vitamin B12 deficiency, hypothyroidism, significant psychiatric disorders (such as major depression or schizophrenia), neurodegenerative disorders, ischaemic stroke, epilepsy, brain tumour, significant head trauma

Any episodes of unexplained loss of consciousness

History of substance or alcohol abuse

Taking an acetylcholinesterase inhibitor, or any other agent demonstrated to affect cognitive function, within the last 3 months

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 313338 0
Hospital
Name [1] 313338 0
St Vincent's Hospital Melbourne
Country [1] 313338 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
41 Victoria Parade
Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 315082 0
None
Name [1] 315082 0
Address [1] 315082 0
Country [1] 315082 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312560 0
St Vincent's Hospital Melbourne HREC
Ethics committee address [1] 312560 0
St Vincent's Hospital Melbourne HREC
Research Governance Unit
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy VIC 3065
Ethics committee country [1] 312560 0
Australia
Date submitted for ethics approval [1] 312560 0
02/11/2022
Approval date [1] 312560 0
13/12/2022
Ethics approval number [1] 312560 0
St Vincent's HREC Ref: 240/22

Summary
Brief summary
The study will assess a potential new method for the early detection of changes in brain function, referred to as Brain Function Fingerprinting or BFF. BFF involves the recording of brain waves (electroencephalogram or EEG) in response to sequences of simple visual or auditory stimuli and analysing the variability of their response. Changes in the variability of the response are hypothesised to indicate changes in brain function. We wish to test the hypothesis that BFF can detect differences between cognitively normal participants and participants suffering from mild dementia due to possible or probable Alzheimer’s Disease.

The study will aim to recruit, over 12 months, a maximum of 24 participants suffering from mild dementia due to possible or probable Alzheimer’s Disease, and 24 of their cognitively normal partners, from the St George’s Hospital. The partners' cognitively normal status will be confirmed by comprehensive clinical evaluation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125090 0
Dr Patrick O'Brien
Address 125090 0
Department of Neurology/Clinical Neurosciences
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy VIC 3065
Country 125090 0
Australia
Phone 125090 0
+61 3 9231 8577
Fax 125090 0
Email 125090 0
patrick.obrien@svha.org.au
Contact person for public queries
Name 125091 0
Dr Patrick O'Brien
Address 125091 0
Department of Neurology/Clinical Neurosciences
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy VIC 3065
Country 125091 0
Australia
Phone 125091 0
+61 3 9231 8577
Fax 125091 0
Email 125091 0
patrick.obrien@svha.org.au
Contact person for scientific queries
Name 125092 0
Dr Patrick O'Brien
Address 125092 0
Department of Neurology/Clinical Neurosciences
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy VIC 3065
Country 125092 0
Australia
Phone 125092 0
+61 3 9231 8577
Fax 125092 0
Email 125092 0
patrick.obrien@svha.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Available after main trial publication with no end date determined
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Dr Patrick O'Brien, Principal Investigator, patrick.obrien@svha.org.au


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.