cognitive impairment Dementia
Conditions
Interventions
None listed
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 99 Years
Inclusion 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
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 - 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| - difference in 36-hour course of proteins in cerebrospinal fluid in healthy elderly subjects, between groups with and without treatment with an anti-inflammatory marker - difference in 36-hour course of proteins in cerebrospinal fluid in healthy elderly subject, between a group in which sampeling starts immediately, and a group in which sampeling starts later Tolerability: o adverse events o vital signs o safety laboratory | — |
Primary
| Measure | Time frame |
|---|---|
| Difference in 36-hour course of different proteins in cerebrospinal fluid between healthy elderly subjects and patients with Alzheimer's disease or Mild Cognitive Impairment | — |
Countries
Netherlands
Outcome results
None listed