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Evolution of Memory Related Activity

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ClinicalTrials.gov Identifier: NCT00902499
Recruitment Status : Unknown
Verified July 2010 by National Institute on Aging (NIA).
Recruitment status was:  Recruiting
First Posted : May 15, 2009
Last Update Posted : July 26, 2010
Information provided by:
National Institute on Aging (NIA)

Brief Summary:
The purpose of this study is to begin the process of validating fMRI (functional magnetic resonance imaging) as a biomarker for use in clinical trials and longitudinal studies of clinical progression in mild cognitive impairment (MCI) and Alzheimer's disease (AD).

Condition or disease
Alzheimer's Disease Mild Cognitive Impairment

Detailed Description:

The development of biomarkers is now especially critical, as there are a number of promising disease-modifying therapies entering early phase clinical trials, with additional novel therapeutic strategies in development. It is essential to develop biomarkers that can detect a "signal of efficacy" over a relatively short time frame for use in Phase II trials. Ideally biomarkers are needed that can reliably detect the earliest brain alterations due to AD pathology, perhaps at a point when there is synaptic dysfunction but not yet widespread neuronal loss. Functional neuroimaging, in particular functional MRI (fMRI), has significant potential, having already shown promise in detecting regionally specific pharmacological effects on memory related neural activity, and as a sensitive marker of very early cognitive impairment.

This study, a parallel ancillary study of the Alzheimer's Disease Neuroimaging Initiative (ADNI), will first examine reproducibility of fMRI activation, using a face-name associative memory paradigm, and then the alterations in memory-related activation that occur over the course of MCI and mild AD. The study will also examine the relationship of fMRI activation to clinical variables, memory task performance, genotype, and other imaging techniques cross-sectionally and longitudinally, sampling at multiple time points over a 3-year period.

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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Evolution of Memory-related fMRI Activation Over the Course of MCI and AD
Study Start Date : May 2006
Estimated Primary Completion Date : May 2011
Estimated Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Normal older controls, not cognitively impaired; MMSE 27-30 and performance above education adjusted cutoff scores on the Logical Memory II subscale (LM-II Delayed Paragraph Recall) of the Wechsler Memory Scale
Very mild cognitive impairment; less severe objective memory deficit, scoring .5 to 1.5 S.D. (standard deviation) below education adjusted norms on the LM-II
significant mild cognitive impairment; objective cut off of 1.5 S.D. level below education adjusted norms on the LM-II
Mild Alzheimer's disease; meet NINCDS/ADRDA criteria for probable AD with mild dementia severity (CDR Total = 1), MMSE 20-26

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Memory Disorders Unit at Brigham and Women's Hospital, the Gerontology Research Unit at Massachusetts General Hospital, Alzheimer's Association, area physicians, and community dwelling adults

Inclusion Criteria:

  • Ages 55-90
  • General good health or stable medical problems
  • Study partner/caregiver able to provide an independent evaluation of the participant's daily functioning
  • No contraindications to MR scanning
  • Modified Hachinski Ischemic Score ≤4
  • Geriatric Depression Scale ≤10

Exclusion Criteria:

  • Diagnosis of Parkinson's disease or other neurological illness
  • Presence of clinically significant/uncontrolled medical conditions
  • History of stroke, brain tumor, brain surgery, seizures, significant head trauma with loss of consciousness, depression or other psychiatric illness, alcohol or drug abuse in the past 2 years
  • Significant uncorrectable visual impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00902499

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Contact: Caroline Sullivan 617-726-6212 csullivan21@partners.org
Contact: Meghan Frey 617-732-8085 mfrey1@partners.org

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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Meghan Frey    617-732-8085    mfrey1@partners.org   
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02129
Contact: Caroline Sullivan    617-726-6212    csullivan21@partners.org   
Sponsors and Collaborators
National Institute on Aging (NIA)
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Principal Investigator: Reisa Sperling, MD Director of Clinical Research, Memory Disorders Unit, Brigham and Women's Hospital
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Responsible Party: Reisa A. Sperling, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00902499    
Other Study ID Numbers: IA0159
5R01AG027435-04 ( U.S. NIH Grant/Contract )
First Posted: May 15, 2009    Key Record Dates
Last Update Posted: July 26, 2010
Last Verified: July 2010
Keywords provided by National Institute on Aging (NIA):
functional magnetic resonance imaging
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders