Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00094952
Status:
UNKNOWN
Last Update Posted:
2009-09-18
First Post:
2004-10-28
Brief Title:
Biomarkers and Early Alzheimers Disease
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
Biomarkers and Early Alzheimers Disease
Status:
UNKNOWN
Status Verified Date:
2009-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main goal of this project is to use imaging and biomarkers to identify cognitively normal elderly people who are at increased risk for developing mild cognitive impairment MCI MCI is the earliest clinically detectable evidence for brain changes due to Alzheimers disease AD The second goal of this project is to describe the inter-relationships among anatomical biomarkers cerebrospinal fluid biomarkers and cognition measures in those elderly people who develop MCI
Detailed Description:
The goal of this project is to use magnetic resonance imaging MRI and cerebrospinal fluid CSF biomarkers to identify cognitively normal participants who show the earliest clinically detectable brain changes of Alzheimers disease AD
The major hypothesis for this study is that CSF P-tau231 measurement improves the accuracy of MRI and cerebrospinal fluid CSF measurements in predicting mild cognitive impairment MCI Validation of this hypothesis can lead to improved diagnostic tools for detecting AD as early as possible
This 5-year longitudinal study will involve a baseline exam and two 18-month followup exams Participants will undergo MRI scans CSF collection and blood samples neuropsychological performance testing and medical neurological and psychiatric assessment The screening and diagnostic evaluations will be carried out by the New York University Alzheimer Disease Core Center ADCC and the NYU Center for Brain Health
This study will enroll a minimum of 80 cognitively normal participants 60 to 80 years of age with English as their first language with about 12 years of formal education and who are living in the metropolitan New York City area All participants will receive baseline and follow-up evaluations to rule out confounding medical neurological and psychiatric conditions that could affect cognition The study coordinator will maintain 6-month telephone contact with all participants and their caregivers who are part of the project
The major hypothesis for this study is that CSF P-tau231 measurement improves the accuracy of MRI and cerebrospinal fluid CSF measurements in predicting mild cognitive impairment MCI Validation of this hypothesis can lead to improved diagnostic tools for detecting AD as early as possible
This 5-year longitudinal study will involve a baseline exam and two 18-month followup exams Participants will undergo MRI scans CSF collection and blood samples neuropsychological performance testing and medical neurological and psychiatric assessment The screening and diagnostic evaluations will be carried out by the New York University Alzheimer Disease Core Center ADCC and the NYU Center for Brain Health
This study will enroll a minimum of 80 cognitively normal participants 60 to 80 years of age with English as their first language with about 12 years of formal education and who are living in the metropolitan New York City area All participants will receive baseline and follow-up evaluations to rule out confounding medical neurological and psychiatric conditions that could affect cognition The study coordinator will maintain 6-month telephone contact with all participants and their caregivers who are part of the project
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AG022374 | None | None | None |