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

Completed

• Conditions: Alzheimer's Dementia, Mild Cognitive Impairment, Mild Cognitive Disorder; Mental and Behavioural Disorders

• Registration Number: ISRCTN10751858
• Lead Sponsor: Cognetivity Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-15
• Last Update Posted: 19 March 2018
• Study Completion: 2019-02-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

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) <28 and > 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) <24 and > 19
3. Males and Females aged 65-80 years
4. Capable of indicating informed consent for participation

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified