An observational study in Alzheimer's Disease, sponsored by Alzheimer's Disease Cooperative Study (ADCS). Completed at 59 sites in 2 countries. Open to participants aged 55 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-16.
Sponsored by Alzheimer's Disease Cooperative Study (ADCS) · Observational
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.
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.
3,675 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.
This study's enrollment of 818 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Alzheimer's Disease Cooperative Study (ADCS) is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
community sample
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:
Mild Cognitive Impairment (MCI); scans performed at screening/baseline, 6, 12, 18, 24, and 36 months
Procedure: Magnetic Resonance Imaging (MRI) · Procedure: Positron Emission Tomography (PET) · Procedure: Lumbar Puncture (LP)
Early Alzheimer's disease (AD); scans performed at screening/baseline, 6, 12, and 24 months
Procedure: Magnetic Resonance Imaging (MRI) · Procedure: Positron Emission Tomography (PET) · Procedure: Lumbar Puncture (LP)
Unaffected/normal controls; scans performed at baseline/screening, 6, 12, 24, and 36 months
Procedure: Magnetic Resonance Imaging (MRI) · Procedure: Positron Emission Tomography (PET) · Procedure: Lumbar Puncture (LP)
MRI scans
PET scans
collection of cerebrospinal fluid
Also known as: spinal tap
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Alzheimer's Disease Cooperative Study (ADCS)