Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106899
Status:
COMPLETED
Last Update Posted:
2014-09-16
First Post:
2005-03-31
Brief Title:
ADNI Alzheimers Disease Neuroimaging Initiative
Sponsor:
Alzheimers Disease Cooperative Study ADCS
Organization:
Alzheimers Disease Cooperative Study ADCS
Study Overview
Official Title:
Alzheimers Disease Neuroimaging Initiative
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
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 purpose of this study is to examine how brain imaging technology can be used with other tests to measure the progression of mild cognitive impairment MCI and early Alzheimers disease AD This information will aid future clinical trials by providing a standard assessment tool to measure the effects of treatments being studied
Detailed Description:
This study will test whether serial magnetic resonance imaging MRI positron emission tomography PET other biological markers and clinical and neuropsychological assessment can be combined to measure the progression of mild cognitive impairment MCI and early Alzheimers disease AD The information obtained by studying changes in the brain images of MCI and AD patients and healthy individuals as well as other assessment tools will be used to determine the best methods for measuring treatment effects in patients with MCI and AD
Approximately 800 participants ranging in age from 55 to 90 will be recruited for the study 400 patients with MCI 200 with early AD and 200 normal controls Patients with MCI and normal controls will be followed for 3 years and those with AD will be followed for 2 years At 6-month intervals all participants will be seen in person or contacted by telephone All participants will undergo repeated scanning and blood and urine biomarkers will be collected at the time of each scan All patients will be asked if they are willing to undergo lumbar puncture at baseline and year one with the goal of a minimum of 20 and as many as 50 of each group providing CSF cerebrospinal fluid samples for analysis and storage for future analyses
NOTE Beginning in Spring 2007 a subset of the ADNI participants will be offered the opportunity to participate in a supplemental study The PIB Pittsburgh Compound B study provides imaging of amyloid plaque burden PIB PET scans will be conducted in 24 control 48 MCI and 24 AD participants at approximately 16 ADNI PET sites For entering participants with no previous PET FDG scans controls and MCI participants will be scanned with PIB at entry baseline 12 24 and 36 months and AD participants will be scanned with PIB at entry baseline 12 and 24 months For participants who have undergone previous baseline and 6 month PET FDG scans controls and MCI participants will be scanned with PIB at 12 24 and 36 months and AD participants will be scanned with PIB at 12 and 24 months
Approximately 800 participants ranging in age from 55 to 90 will be recruited for the study 400 patients with MCI 200 with early AD and 200 normal controls Patients with MCI and normal controls will be followed for 3 years and those with AD will be followed for 2 years At 6-month intervals all participants will be seen in person or contacted by telephone All participants will undergo repeated scanning and blood and urine biomarkers will be collected at the time of each scan All patients will be asked if they are willing to undergo lumbar puncture at baseline and year one with the goal of a minimum of 20 and as many as 50 of each group providing CSF cerebrospinal fluid samples for analysis and storage for future analyses
NOTE Beginning in Spring 2007 a subset of the ADNI participants will be offered the opportunity to participate in a supplemental study The PIB Pittsburgh Compound B study provides imaging of amyloid plaque burden PIB PET scans will be conducted in 24 control 48 MCI and 24 AD participants at approximately 16 ADNI PET sites For entering participants with no previous PET FDG scans controls and MCI participants will be scanned with PIB at entry baseline 12 24 and 36 months and AD participants will be scanned with PIB at entry baseline 12 and 24 months For participants who have undergone previous baseline and 6 month PET FDG scans controls and MCI participants will be scanned with PIB at 12 24 and 36 months and AD participants will be scanned with PIB at 12 and 24 months
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 |
|---|---|---|---|
| 1U01AG024904 | NIH | None | httpsreporternihgovquickSearch1U01AG024904 |
| 1RC2AG036535 | NIH | None | None |