Blood-brain Barrier Permeability in Alzheimer's Disease

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01574456

Enrollment

Registered

2012-04-10

Start date

2012-03-31

Completion date

2013-12-31

Last updated

2013-12-10

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

Conditions

Alzheimer's Disease

Brief summary

The main aim of the present study is to improve our understanding of the role of blood-brain barrier function in dementia of the Alzheimer's type. The investigators hypothesize that microvascular dysfunction - more specifically cerebral perfusion and blood-brain barrier leakage - is a determinant of cognitive decline and cortical atrophy in Alzheimer's disease.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

Patients with AD: * Informed consent before participation in the study * Received standard diagnostic procedure according to the Parelsnoer Initiative procedure * Diagnosed with dementia of the Alzheimer's type * Clinical dementia rating (CDR) of 1, which means a mild to moderate stage of dementia * MMSE ≥ 20 and patients are mentally competent (in general, individuals with an MMSE ≥ 18 are considered mentally competent) Patients with prodromal AD: * Informed consent before participation in the study * Received standard diagnostic procedure according to the Parelsnoer Initiative procedure * Diagnosis of prodromal dementia according to the Dubois criteria (16) * CDR of 0.5, which suggests a very mild stage of dementia * Memory impairment defined as Delayed Recall on Verbal Learning Test (15 WLT) \< 1.5 SD * MMSE ≥ 20 and patients are mentally competent. * Medial temporal lobe atrophy scale MTA ≥ 1 (17) OR abnormal levels of Aß42, t-tau or p-tau Healthy participants: * Informed consent before participation in the study * No Diagnosis of dementia, prodromal dementia, or mild cognitive impairment. * MMSE ≥ 26 * No substantial memory complaints (according to participant) * Age, gender and education is matched to the patient groups.

Exclusion criteria

* Contraindications for scanning (e.g. brain surgery, cardiac pacemaker, metal implants, claustrophobia, large body tattoos) * Contraindications for contrast agent Gadovist (renal failure) as determined by the estimated Glomular Filtration Rate eGFR \< 30 mL/min. * Major vascular disorders (e.g. stroke, heart disease) * Psychiatric or neurological disorders: Major depression (\< 12 months); history of schizophrenia; bipolar disorder; psychotic disorder NOS or treatment for a psychotic disorder (\< 12 mnd); cognitive impairment due to alcohol abuse; epilepsy; Parkinson's disease; MS; brain surgery; brain trauma; electroshock therapy; kidney dialysis; Meniere's disease; and brain infections. * Structural abnormalities of the brain * Cognitive impairment due to alcohol/drug abuse * Absence of reliable informant (for patient groups)

Design outcomes

Primary

Measure	Time frame
The main study measures are blood brain barrier permeability as measured by T1-weighted dynamic contrast MRI	22 months

Countries

Netherlands

Outcome results