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

Blood-brain barrier permeability, inflammation, and clinical progression in Alzheimer's disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN17419165
Enrollment
70
Registered
2024-05-21
Start date
2023-12-22
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Alzheimers disease, dementia Nervous System Diseases

Interventions

At the start of the study, all participants will be given information about the study by a researcher. The researcher will also answer any questions about the study. If they are happy to take part, th

Sponsors

University of Southampton
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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).

Design outcomes

Primary

MeasureTime frame
Blood-brain barrier permeability is measured using dynamic contrast-enhanced MRI at baseline

Secondary

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

Countries

England, United Kingdom

Outcome results

None listed

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