Permeability of the blood-brain barrier in Alzheimer’s disease

Not Applicable

Conditions: Alzheimer's disease, dementia
Nervous System Diseases

Registration Number: ISRCTN17419165

Lead Sponsor: niversity of Southampton

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 70

Inclusion Criteria

1. Age > 50 years old, no upper limit.
2. Able and willing to give informed consent for participation in the study at baseline.
3. AD participants: meet international consensus criteria for a diagnosis of AD dementia or mild cognitive impairment secondary to AD.
or
Control participants: no cognitive impairment and a MoCA score greater than, or equal to, 26 at baseline.

Exclusion Criteria

1. Lack capacity to provide informed consent at baseline or decline to participate.
2. Not proficient in English language.
3. Absence of a reliable study partner (AD participants only).
4. Diagnosis of mixed dementia or another central nervous system disease (e.g. multiple sclerosis, stroke).
5. Intercurrent acute kidney injury, infection, or delirium.
6. History or presence of major psychiatric disorder or alcohol/substance misuse, within the last two years.
7. Diagnosis of any severe inflammatory disorder (e.g. rheumatoid arthritis, periodontitis, inflammatory bowel disease, chronic/recurrent gingivitis).
8. Use of non-topical steroids or cytokine modulators.
9. Previous brain imaging showing confluent white matter changes reflective of gross cerebrovascular disease.
10. Impaired renal function that absolutely contraindicates contrast-enhanced MRI (eGFR < 40).
11. Any contraindication for MRI (e.g. claustrophobia, implanted MR-unsafe metalwork, known hypersensitivity to contrast agent).

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood-brain barrier permeability is measured using dynamic contrast-enhanced MRI at baseline

Secondary Outcome Measures

Name	Time	Method
1. Inflammation is measured using single molecule array assays on plasma and mass spectrometry on urine, at baseline, 1 year and 2 years<br>2. Cognition is measured using the Addenbrooke’s Cognitive Examination (ACE) and Montreal Cognitive Examination (MoCA), at baseline, 1 year and 2 years