Blood-brain Barrier Permeability in Alzheimer's Disease

Alzheimer's Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01574456
• Other study ID #: NL36156.068.11
• Status: Completed
• Phase: N/A
• First received: April 5, 2012
• Last updated: December 9, 2013
• Start date: March 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Locations

Country	Name	City	State
Netherlands	Leids University Medical Center	Leiden
Netherlands	Maastricht University Hospital	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The main study measures are blood brain barrier permeability as measured by T1-weighted dynamic contrast MRI		22 months	No