A Biomarker Study to Measure CSF Proteins Upon Application of an Indwelling Lumbar Catheter for 36 Hours in Subjects with Mild Cognitive Impairment or Alzheimer*s Disease
- Conditions
- cognitive impairmentDementia10057167
- Registration Number
- NL-OMON37828
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 20
o Diagnosis of probable or possible AD (according to NINCDS-ADRDA)
o Mini Mental State Exam score of *18 at screening
o Signed informed consent, and subjects must have signed a separate written informed consent indicating willingness to participate in Part 1 genetic testing (required), and indicate either consent or refusal for Part 2 DNA storage (optional)
o Mentally capable of understanding the implications of study participation
o For MCI subjects only: biological evidence for AD (evidenced by hippocampal atrophy on MRI, positive PIB scan or a positive AD CSF biomarker pattern based on changes on A* (decrease), t-tau and p-tau (increase)
o Clinically significant abnormal physical- or neurological examination (including fundoscopy), vital signs or 12-lead ECG at screening.
o Has a relevant history of lower back pain or scoliosis and/or major (lumbar) back surgery (microdiscectomy is allowed).
o Relevant history of or current neurological disease other than AD/MCI (including any history of postdural puncture headache).
o History of epilepsy or fits or unexplained black-outs.
o History or family history of abnormal bleeding or of blood clotting
o History of spontaneous, prolonged or severe bleeding with unclear origin.
o Positive screen for drugs or alcohol
o Current anemia
o Allergic to local anesthetics and/or chlorhexidine.
o Inability to refrain from
- Low Molecular Weight Heparin (LMWH) treatment within 12 hours prior to spinal
- Other anticoagulant treatment (besides LMWH described above) within 1 week prior to spinal catheter insertion.
- Aspirin treatment (even low dose) within 5 days prior to spinal catheter insertion.
o At pre-check:
- Topical infection or local dermatological condition at the puncture site prior to puncture (pre-puncture Day 1).
- Clinically significant acute illness within 7 days prior to the study
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Difference in 36-hour course of different proteins in cerebrospinal fluid<br /><br>between healthy elderly subjects and patients with Alzheimer's disease or Mild<br /><br>Cognitive Impairment</p><br>
- Secondary Outcome Measures
Name Time Method <p>- difference in 36-hour course of proteins in cerebrospinal fluid in healthy<br /><br>elderly subjects, between groups with and without treatment with an<br /><br>anti-inflammatory marker<br /><br>- difference in 36-hour course of proteins in cerebrospinal fluid in healthy<br /><br>elderly subject, between a group in which sampeling starts immediately, and a<br /><br>group in which sampeling starts later<br /><br><br /><br>Tolerability:<br /><br>o adverse events<br /><br>o vital signs<br /><br>o safety laboratory</p><br>