A Study to Measure CSF Proteins in Elderly Healthy Volunteers and Volunteers With Mild Cognitive Impairment or Alzheimer's Disease
Condition: Healthy; Alzheimer Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to investigate changes of cerebral spinal fluid (CSF) proteins
      over time using continuous CSF sampling for 36 hours in elderly healthy volunteers and
      volunteers with mild cognitive impairment or Alzheimer's Disease.
    

Detailed description: 
      This is a study to measure specific proteins in the cerebral spinal fluid (CSF) of healthy
      elderly volunteers and volunteers with mild cognitive impairment (MCI) or Alzheimer's Disease
      (AD). No investigational medical drug will be given to volunteers during their participation
      in this study. Healthy elderly volunteers will be enrolled in Part A of the study and will be
      randomized (assigned by chance) to 1 of 4 cohorts (groups); each cohort of volunteers will
      undergo a different type of CSF sampling procedure (a standard frequent CSF sampling
      procedure, an alternative frequency of CSF sampling procedure, or the standard frequent CSF
      sampling procedure with 800 mg ibuprofen administered to volunteers on Day 1, or an
      alternative lower frequency of CSF sampling in comparison to Cohort 1) and will have blood
      samples collected. Volunteers with MCI or AD will be enrolled in Part B of the study and will
      undergo 1 CSF sampling procedure (ie, the standard frequent CSF sampling procedure). In
      addition, all volunteers enrolled who consent (agree) to the pharmacogenomic component of the
      study, will have a blood sample collected that will allow for genetic research to help
      understand the link between Alzheimer's Disease biomarker profiles and specific genotypes and
      to have their DNA samples stored for future genetic research related to CSF proteins and
      Alzheimer's Disease. Participation in the pharmacogenomic research is optional for volunteers
      enrolled in Part A Cohort 1 to 3 but required for volunteers enrolled in Part A Cohort 5 and
      Part B. Participation in the DNA storage component is optional and refusal to participate
      will not result in ineligibility for the main part of the study. There will be no blinding in
      this study (ie, volunteers will know the CSF sampling procedure being performed on them). CSF
      and blood samples will be collected over a period of 36 hours and the maximum duration of the
      study will be no more than 6 weeks. During the study, volunteers will be monitored to
      evaluate the safety and tolerability of the CSF sampling procedures.
    

Intervention name(s): Standard CSR sampling procedure; Alternate frequency CSR sampling procedure; Standard frequent CSR sampling procedure with 800 mg ibuprofen; Standard CSR sampling procedure; Alternative lower frequency CSR sampling procedure
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Procedure
Intervention description(s): standard frequent CSF sampling procedure for 36 hours; an alternative frequency of CSF sampling procedure for 36 hours; standard frequent CSF sampling procedure on Day 1 for 36 hours with 800 mg Ibuprofen administered on Day 1; standard frequent CSF sampling procedure for 36 hours.; an alternative lower frequency of CSF sampling procedure in comparison to Cohort 1 for 36 hours
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Biological Markers; Healthy Volunteer; Alzheimer's Disease (AD); Mild Cognitive Impairment (MCI); Cerebrospinal fluid (CSF); CSF proteins