An observational study of factors influencing age of onset of Alzheimer’s disease and disease progressio

Not Applicable

• Conditions: Nervous System Diseases; Alzheimer's disease

• Registration Number: ISRCTN24454186
• Lead Sponsor: lster University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-03
• Last Update Posted: 27 July 2020
• Study Completion: 2029-10-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Inclusion criteria for age of onset Alzheimer’s disease patients:
1. Male and female participants
2. Aged between 45-84
3. Diagnosis of Alzheimer’s disease (50 aged 45-54, 50 aged 55-64, 50 aged 65-74, 50 aged 75-84)

Inclusion criteria for ‘other dementia’ group in age of onset study:
1. Male and female participants
2. Aged between 45-84
3. With an ‘other’ diagnosis of dementia (i.e. NOT Alzheimer’s disease) including but not limited to: Vascular Dementia (VaD), Frontotemporal dementia (FTD), Dementia with Lewy Bodies (DLB)

Inclusion criteria for MCI group in age of onset study:
1. Male and female participants
2. Aged between 45-84
3. A diagnosis of Mild Cognitive Impairment (MCI)

Inclusion criteria for apparently healthy cohort in age of onset study:
1. Men and women
2. Aged between 45-84 (50 aged 45-54, 50 aged 55-64, 50 aged 65-74, 50 aged 75-84)

Inclusion criteria for imaging sub study:
1. Men and women
2. Aged 45-84
3. Diagnosis of MCI, Alzheimer’s disease, other dementia and healthy controls (25 per group)

Exclusion Criteria

Exclusion criteria for all age of onset participants:
Participants with a bleeding disorder, for which, blood sampling would not be advisable.

Exclusion criteria for imaging sub study:
1. Participants with a bleeding disorder, for which blood sampling would not be advisable
2. Pregnancy
3. Previous head or neck surgery
4. Suffer from epilepsy or migraine
5. Active implants (pacemaker, neurostimulator, insulin pump, ossicular prosthesis)
6. May have metal fragments in the body
7. Have jewellery/piercings that cannot be removed
8. Suffer from claustrophobia

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. A comprehensive database of blood-based biomarkers, comorbidities and medical history associated with age of Alzheimer’s disease onset is asessed using blood based-biomarkers, information from a health and lifestyle questionnaire and from electronic patient notes at baseline (time of recruitment)<br> 2. To assess whether MEG imaging analysis increases specificity of diagnosis and has predictive value with respect to disease progression is measured using magnetoencephalography (MEG) imaging within 6 weeks of baseline (time of recruitment). Predictive value will be measured from 10 year follow up of patient notes.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Markers common to age of onset is measured using genetic, proteomic, metabolic and microbiome analysis of blood samples provided at baseline (time of recruitment)<br> 2. Markers associated with rate of cognitive decline is measured using using genetic, proteomic, metabolic and microbiome analysis of blood samples provided at baseline (time of recruitment) correlated with follow up analysis of patient clinical notes annually for 10 years to assess speed of Alzheimer’s disease progression<br>