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Using a combination of brain imaging techniques and biomarkers for early diagnosis of dementia

Employing combined neuroimaging techniques and CSF biomarkers to characterise spatiotemporal dynamics in Dementia and Mild Cognitive Impairment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10751858
Enrollment
90
Registered
2018-02-15
Start date
2018-03-01
Completion date
Unknown
Last updated
2018-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Dementia, Mild Cognitive Impairment, Mild Cognitive Disorder Mental and Behavioural Disorders Alzheimer's Dementia, Mild Cognitive Impairment, Mild Cognitive Disorder

Interventions

All study participants including healthy controls undergo the following interventions. At screening assessment participants undergo the following assessments: 1. Rapid categorisation task- 5-6 minute

Sponsors

Cognetivity Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Control group: 1. Addenbrooke’s Cognitive Examination (Revised/III) score of above 84 2. Bristol Activities of Daily Living Scale score of “unimpaired” or “mildly impaired” 3. Capacity to understand the information about the study and to give consent to participate 4. Males and females aged between 65-80 years 5. Not currently on medication that may interfere with the study results 6. In good general health 7. Matched for age and education MCI group 1. A clinical diagnosis of MCI according to ICD-10 criteria, diagnosed by an Old Age Psychiatrist 2. Mini Mental State Examination (MMSE) 24 3. Males and Females aged 65-80 years 4. Capable of indicating informed consent for participation Mild-AD group 1. A clinical diagnosis of Mild-AD according to ICD-10 criteria, diagnosed by an Old Age Psychiatrist 2. Mini Mental State Examination (MMSE) 19 3. Males and Females aged 65-80 years 4. Capable of indicating informed consent for participation

Exclusion criteria

Exclusion criteria: Control group 1. Presence of significant cerebrovascular disease ie. History of CVA 2. Major medical co-morbidities e.g. Congestive Cardiac Failure, Diabetes Mellitus with renal impairment 3. Major psychiatric disorder eg. Chronic psychosis, recurrent depressive disorder, generalized anxiety disorder 4. The use of cognitive enhancing drugs e.g. cholinesterase inhibitors 5. A concurrent diagnosis of epilepsy 6. A history of alcohol misuse 7. A history of illicit drug use 8. A history of severe visual impairment, e.g. macular degeneration, diabetic retinopathy, as determined by the clinical team 9. A history of repeated head trauma MCI group 1. Patients who fulfill criteria for a diagnosis of Mild AD 2. Major medical co-morbidities e.g. Congestive Cardiac Failure, Diabetes Mellitus with renal impairment 3. Major psychiatric disorder eg. Chronic psychosis, recurrent depressive disorder, generalized anxiety disorder 4. The use of cognitive enhancing drugs e.g. cholinesterase inhibitors 5. A concurrent diagnosis of epilepsy 6. A history of alcohol misuse 7. A history of illicit drug use Mild-AD group 1. Patients who fulfill criteria for a diagnosis of Moderate AD or Other Mild Dementias 2. Major medical comorbidities e.g. Congestive Cardiac Failure, Diabetes Mellitus with renal impairment 3. Major psychiatric disorder eg. Chronic psychosis, recurrent depressive disorder, generalized anxiety disorder 4. A concurrent diagnosis of epilepsy 5. A history of alcohol misuse 6. A history of illicit drug use 7. A history of severe visual impairment, e.g. macular degeneration, diabetic retinopathy, as determined by the clinical team 8. A history of repeated head trauma 9. MMSE scores less than 19 10. Presence of Sleep Apnoea

Design outcomes

Primary

MeasureTime frame
1. BOLD responses are measured using fMRI in <12 weeks after screening (i.e. baseline) 2. Neural activity on the skull is measured using electroencephalography (EEG) in <12 weeks after the first screening (i.e. baseline) session, and this will be one week before or after the fMRI session (in random order) 3. Level of amyloid beta and cis-p-tau-a is measured from the CSF samples for MCI patients at any time, up to three months after the baseline 4. Level of cognitive performance is measured using MoCA, ACE-R, and ICA at the baseline

Secondary

MeasureTime frame
There are no secondary outcome measures.

Countries

Iran

Contacts

Public ContactSeyed;Chris Mahdi Khaligh-Razavi;Kalafatis

;

Seyed@cognetivity.com;chris@cognetivity.com+98 21 22306485; +44 7824 425 854

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026