Alzheimer's DiseaseNCT01574456
Blood-brain Barrier Permeability in Alzheimer's Disease
An observational study of Alzheimer's Disease, run by Maastricht University Medical Center at 2 sites in Netherlands.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- How many people
- 39 participants
- Where
- 2 sitesNetherlands
- Study dates
- Mar 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Show all 20Show fewer
- 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.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Leids University Medical Center
Leiden, 2333 ZA
Maastricht University Hospital
Maastricht, 6229 ET
About this study
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
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 7 patients diagnosed with dementia of the Alzheimer's type | Not described | |
| 13 patients with mild cognitive impairment | Not described | |
| 19 healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main study measures are blood brain barrier permeability as measured by T1-weighted dynamic contrast MRI
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574456
- Sponsor's protocol ID
- NL36156.068.11
- Status last verified
- Dec 2013
- First submitted
- 5 Apr 2012
- Last updated
- 10 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood-brain Barrier Permeability in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01574456
- Acronym / sponsor ID
- NL36156.068.11
- Conditions
- Alzheimer's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 10 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 7 patients diagnosed with dementia of the Alzheimer's type | – | – |
| 13 patients with mild cognitive impairment | – | – |
| 19 healthy controls | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (20 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The main study measures are blood brain barrier permeability as measured by T1-weighted dynamic contrast MRI
Time frame: 22 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease, run by Maastricht University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main study measures are blood brain barrier permeability as measured by T1-weighted dynamic contrast MRI (time frame: 22 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2013.