NCT00902499

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2006

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

July 26, 2010

Status Verified

July 1, 2010

Enrollment Period

5 years

First QC Date

May 13, 2009

Last Update Submit

July 23, 2010

Conditions

Alzheimer's DiseaseMild Cognitive Impairment

Keywords

functional magnetic resonance imaging

Study Arms (4)

NC

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

vMCI

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

sMCI

significant mild cognitive impairment; objective cut off of 1.5 S.D. level below education adjusted norms on the LM-II

AD

Mild Alzheimer's disease; meet NINCDS/ADRDA criteria for probable AD with mild dementia severity (CDR Total = 1), MMSE 20-26

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02129, United States

RECRUITING

Related Publications (4)

  • Sperling R, Greve D, Dale A, Killiany R, Holmes J, Rosas HD, Cocchiarella A, Firth P, Rosen B, Lake S, Lange N, Routledge C, Albert M. Functional MRI detection of pharmacologically induced memory impairment. Proc Natl Acad Sci U S A. 2002 Jan 8;99(1):455-60. doi: 10.1073/pnas.012467899. Epub 2001 Dec 26.

    PMID: 11756667BACKGROUND

  • Sperling RA, Bates JF, Chua EF, Cocchiarella AJ, Rentz DM, Rosen BR, Schacter DL, Albert MS. fMRI studies of associative encoding in young and elderly controls and mild Alzheimer's disease. J Neurol Neurosurg Psychiatry. 2003 Jan;74(1):44-50. doi: 10.1136/jnnp.74.1.44.

    PMID: 12486265BACKGROUND

  • Greicius MD, Srivastava G, Reiss AL, Menon V. Default-mode network activity distinguishes Alzheimer's disease from healthy aging: evidence from functional MRI. Proc Natl Acad Sci U S A. 2004 Mar 30;101(13):4637-42. doi: 10.1073/pnas.0308627101. Epub 2004 Mar 15.

    PMID: 15070770BACKGROUND

  • Grundman M, Petersen RC, Ferris SH, Thomas RG, Aisen PS, Bennett DA, Foster NL, Jack CR Jr, Galasko DR, Doody R, Kaye J, Sano M, Mohs R, Gauthier S, Kim HT, Jin S, Schultz AN, Schafer K, Mulnard R, van Dyck CH, Mintzer J, Zamrini EY, Cahn-Weiner D, Thal LJ; Alzheimer's Disease Cooperative Study. Mild cognitive impairment can be distinguished from Alzheimer disease and normal aging for clinical trials. Arch Neurol. 2004 Jan;61(1):59-66. doi: 10.1001/archneur.61.1.59.

    PMID: 14732621BACKGROUND

MeSH Terms

Conditions

Alzheimer DiseaseCognitive Dysfunction

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • Reisa Sperling, MD

    Director of Clinical Research, Memory Disorders Unit, Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Sullivan

CONTACT

617-726-6212csullivan21@partners.org

Meghan Frey

CONTACT

617-732-8085mfrey1@partners.org

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH

Study Record Dates

First Submitted

May 13, 2009

First Posted

May 15, 2009

Study Start

May 1, 2006

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

July 26, 2010

Record last verified: 2010-07

Locations

US(2)