Blood-brain Barrier Permeability in Alzheimer's Disease

NCT01574456 | Completed

• 1 other identifier: NL36156.068.11
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 2

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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• The main study measures are blood brain barrier permeability as measured by T1-weighted dynamic contrast MRI

  22 months

Study Arms (3)

7 patients diagnosed with dementia of the Alzheimer's type

13 patients with mild cognitive impairment

19 healthy controls

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Three groups of participants have been included: 7 patients diagnosed with dementia of the Alzheimer's type; 13 patients with mild cognitive impairment due to AD, which represents a preclinical stage of AD in which patients already have memory impairment and at least one AD biomarker (i.e. hippocampal atrophy or abnormal amyloid and tau protein content in the cerebrospinal fluid); and 19 healthy controls. Patients have been recruited from the memory clinics of the Maastricht University Medical Center and the Leiden University Medical Center.

You may qualify if:

• 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:

You may not qualify if:

• 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)

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (2)

Leids University Medical Center

Leiden, 2333 ZA, Netherlands

Location

Maastricht University Hospital

Maastricht, 6229 ET, Netherlands

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2012
• First Posted: April 10, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 10, 2013

Record last verified: 2013-12

Locations

NL (2)