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Evolution of Memory Related Activity

Evolution of Memory-related fMRI Activation Over the Course of MCI and AD

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00902499
Enrollment
160
Registered
2009-05-15
Start date
2006-05-31
Completion date
2011-05-31
Last updated
2010-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease, Mild Cognitive Impairment

Keywords

functional magnetic resonance imaging

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).

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.

Interventions

None listed

Sponsors

National Institute on Aging (NIA)
Lead SponsorNIH

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
Yes

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

Countries

United States

Contacts

Primary ContactCaroline Sullivan
csullivan21@partners.org617-726-6212
Backup ContactMeghan Frey
mfrey1@partners.org617-732-8085

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026