Recruiting

Observational Study

Sponsor:

National Institute on Aging (NIA)

Code:

NCT00902499

Conditions

Alzheimer's Disease

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Accepted

Study Details

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).

Conditions

Alzheimer's Disease

Mild Cognitive Impairment

Study ID

NCT00902499

Start date

May, 2006

Status verified date

Jul, 2010

Completion date

May, 2011

Anticipated

Primary completion date

May, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

160 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Central Contacts and Locations

Central contacts

Caroline Sullivan

617-726-6212csullivan21@partners.org

Meghan Frey

617-732-8085mfrey1@partners.org

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Meghan Frey

617-732-8085mfrey1@partners.org

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02129

Contacts

Caroline Sullivan

617-726-6212csullivan21@partners.org

More Information

Sponsor

National Institute on Aging (NIA)

Last update posted

Jul 26, 2010

Last verified

Jul, 2010

Keywords

  • functional magnetic resonance imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute on Aging (NIA) on 2010-07-26.