Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Blood-brain Barrier Permeability in Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01574456
Recruitment Status : Completed
First Posted : April 10, 2012
Last Update Posted : December 10, 2013
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Tracking Information
First Submitted Date April 5, 2012
First Posted Date April 10, 2012
Last Update Posted Date December 10, 2013
Study Start Date March 2012
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 9, 2013)
The main study measures are blood brain barrier permeability as measured by T1-weighted dynamic contrast MRI [ Time Frame: 22 months ]
Original Primary Outcome Measures
 (submitted: April 9, 2012)
The main study measures are blood brain barrier permeability as measured by T1-weighted dynamic contrast MRI [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Blood-brain Barrier Permeability in Alzheimer's Disease
Official Title Not Provided
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Alzheimer's Disease
Intervention Not Provided
Study Groups/Cohorts
  • 7 patients diagnosed with dementia of the Alzheimer's type
  • 13 patients with mild cognitive impairment
  • 19 healthy controls
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 9, 2013)
39
Original Estimated Enrollment
 (submitted: April 9, 2012)
60
Actual Study Completion Date December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT01574456
Other Study ID Numbers NL36156.068.11
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Maastricht University Medical Center
Study Sponsor Maastricht University Medical Center
Collaborators Not Provided
Investigators Not Provided
PRS Account Maastricht University Medical Center
Verification Date December 2013