NL-OMON37828
Withdrawn
Not Applicable
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 - CSF biomarker study in patients with MCI or Alzheimer's Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- cognitive impairment
- Sponsor
- Janssen-Cilag
- Enrollment
- 20
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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