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| Sponsor: | Alzheimer's Disease Cooperative Study (ADCS) |
|---|---|
| Collaborators: |
Northern California Institute for Research and Education (NCIRE) National Institute on Aging (NIA) National Institute for Biomedical Imaging and Bioengineering (NIBIB) Foundation for the National Institutes of Health Alzheimer’s Drug Discovery Foundation Alzheimer's Association |
| Information provided by (Responsible Party): | Alzheimer's Disease Cooperative Study (ADCS) |
| ClinicalTrials.gov Identifier: | NCT00106899 |
Purpose
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 Alzheimer's disease (AD). This information will aid future clinical trials by providing a standard assessment tool to measure the effects of treatments being studied.
| Condition | Intervention |
|---|---|
|
Alzheimer's Disease |
Procedure: Magnetic Resonance Imaging (MRI) Procedure: Positron Emission Tomography (PET) Procedure: Lumbar Puncture (LP) |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Alzheimer's Disease Neuroimaging Initiative |
blood, urine, cerebrospinal fluid
| Enrollment: | 818 |
| Study Start Date: | July 2005 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Mild Cognitive Impairment (MCI); scans performed at screening/baseline, 6, 12, 18, 24, and 36 months
|
Procedure: Magnetic Resonance Imaging (MRI)
MRI scans
Procedure: Positron Emission Tomography (PET)
PET scans
Procedure: Lumbar Puncture (LP)
collection of cerebrospinal fluid
Other Name: spinal tap
|
|
2
Early Alzheimer's disease (AD); scans performed at screening/baseline, 6, 12, and 24 months
|
Procedure: Magnetic Resonance Imaging (MRI)
MRI scans
Procedure: Positron Emission Tomography (PET)
PET scans
Procedure: Lumbar Puncture (LP)
collection of cerebrospinal fluid
Other Name: spinal tap
|
|
3
Unaffected/normal controls; scans performed at baseline/screening, 6, 12, 24, and 36 months
|
Procedure: Magnetic Resonance Imaging (MRI)
MRI scans
Procedure: Positron Emission Tomography (PET)
PET scans
Procedure: Lumbar Puncture (LP)
collection of cerebrospinal fluid
Other Name: spinal tap
|
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 Alzheimer's 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.
Eligibility| Ages Eligible for Study: | 55 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
community sample
Inclusion Criteria:
Participants will be classified as either MCI patients, AD patients, or normal controls. General Inclusion Criteria will apply to all groups, with specific criteria for each group as described below:
General (applies to each category):
Specific Criteria for MCI and AD patients:
Exclusion Criteria:
Specific Exclusion Criteria for MCI and AD:
Prohibited medications:
Contacts and Locations
Show 59 Study Locations| Principal Investigator: | Michael W. Weiner, MD | University of California, San Francisco |
| Principal Investigator: | Ronald Petersen, MD, PhD | Mayo Clinic, Rochester, Minnesota |
| Principal Investigator: | Paul Aisen, MD | University of California, San Diego |
More Information
| Responsible Party: | Alzheimer's Disease Cooperative Study (ADCS) |
| ClinicalTrials.gov Identifier: | NCT00106899 History of Changes |
| Other Study ID Numbers: | IA0068, 1RC2AG036535, 1U01AG024904 |
| Study First Received: | March 31, 2005 |
| Last Updated: | January 18, 2012 |
| Health Authority: | United States: Federal Government |
|
neuroimaging brain metabolism biomarkers cognition disorder Mild Cognitive Impairment |
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |