ADNI: Alzheimer's Disease Neuroimaging Initiative

This study has been completed.
Sponsor:
Collaborators:
Northern California Institute of Research and Education
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
First received: March 31, 2005
Last updated: September 15, 2014
Last verified: September 2014
  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

Resource links provided by NLM:


Further study details as provided by Alzheimer's Disease Cooperative Study (ADCS):

Biospecimen Retention:   Samples With DNA

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

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 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
Study Population

community sample

Criteria

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):

  • Between 55 and 90 years of age (Currently, ADNI sites are only recruiting volunteers age 70-90 among people with no memory problems)
  • Study partner or caregiver to accompany patient to all scheduled visits
  • Fluent in English or Spanish
  • Permitted medications stable for at least 4 weeks prior to screening
  • Adequate visual and auditory acuity to allow neuropsychological testing
  • Good general health with no additional diseases expected to interfere with the study
  • Women must be two years post-menopausal or surgically sterile
  • Willing and able to complete all baseline assessments, and to participate in the 2-3 year protocol
  • Willing to undergo neuroimaging and provide DNA and plasma samples as specified
  • Completed 6 grades of education or sufficient work history to exclude mental retardation
  • Modified Hachinski score <=4
  • Geriatric Depression Scale <6

Specific Criteria for MCI and AD patients:

  • Memory complaint by patient or study partner
  • Abnormal memory function score on Wechsler Memory Scale (adjusted for education)
  • Mini-Mental State Exam score between 24 and 30 (MCI) or 20 and 26 (AD)
  • Clinical Dementia Rating = 0.5; Memory Box score at least 0.5 (MCI) or 1.0 (AD)

Exclusion Criteria:

  • Any significant neurologic disease other than Alzheimer's disease
  • Abnormal baseline MRI
  • Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin, or body
  • Major depression, bipolar disorder, history of schizophrenia
  • History of alcohol or substance abuse or dependency within the past 2 years
  • Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol
  • Clinically significant laboratory abnormalities
  • Residence in skilled nursing facility
  • Participation in clinical studies involving neuropsychological measures being collected more than one time per year

Specific Exclusion Criteria for MCI and AD:

  • Psychotic features, agitation or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol.

Prohibited medications:

  • Specific psychoactive medications (for example, certain antidepressants, anti-anxiety medications, sleeping pills, etc.)
  • Warfarin (Coumadin)
  • Investigational agents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106899

  Show 59 Study Locations
Sponsors and Collaborators
Alzheimer's Disease Cooperative Study (ADCS)
Northern California Institute of Research and Education
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Foundation for the National Institutes of Health
Alzheimer’s Drug Discovery Foundation
Alzheimer's Association
Investigators
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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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: September 15, 2014
Health Authority: United States: Federal Government

Keywords provided by Alzheimer's Disease Cooperative Study (ADCS):
neuroimaging
brain metabolism
biomarkers
cognition disorder
Mild Cognitive Impairment

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on October 23, 2014