Improved Diagnosis of Alzheimer's Disease Using Magnetoencephalography (MEG)

NCT00973518 | Completed

• 1 other identifier: ADD 09-02
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 2

Brief Summary

The current study is intended to enrich and extend the database of Alzheimer's Disease (AD) and healthy control (HC) MEG scans and will include patients meeting DSM-IV-TR criteria for dementia of Alzheimer's type, and age- and gender-matched HC subjects meeting criteria of normal neurological function. This study will include 2 MEG and electroencephalography (EEG) scans on approximately 80 AD subjects and 80 HC subjects over approximately 30 days. All subjects will have MEG/EEG scans at baseline and 28 - 35 days after baseline. Within one day of each scan visit AD subjects will undergo 4 standard functional tests while HC subjects will undergo 2 standard functional tests. This study will test the following hypotheses:

• MEG scans of resting-state, eyes-open brain function reveal patterns of correlated activity that differ between HC subjects and subjects diagnosed with dementia of Alzheimer's type;
• Patterns of correlated activity measured in AD subjects correspond to other measures of disease severity such as standard functional test scores;
• MEG scan patterns for HC subjects are consistent across repeated measures taken over a 30 day period.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease; AD; Healthy Control

Outcome Measures

Primary Outcomes (2)

• Identification and characterization of patterns of correlated brain activity measured by MEG and the Orasi SNI test that differ consistently (e.g. at all evaluation time points) between HC and AD subjects

  approximately 30 days

• Identification and characterization of patterns of correlated brain activity measured by MEG and the Orasi SNI test that differ across time points within single subjects and across groups of HC and AD subjects

  Approximately 30 days

Secondary Outcomes (3)

• Identification and characterization of Orasi SNI test features that correlate with independent measures of cognitive function based on functional testing (ADAS-Cog sum of boxes, and MMSE raw score, One Card Learning Test)

  Approximately 30 days

• Identification and characterization of Orasi SNI test features that correlate with AD medications being taken by AD subjects

  Approximately one month

• Identification, characterization and comparison of scan results generated by MEG and EEG

  Approximately one month

Study Arms (2)

Alzheimer's Disease subjects

Subjects diagnosed with dementia of Alzheimer's type (DSM-IV-TR).

Healthy Control subjects

Age \& gender-matched subjects determined to be healthy.

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The current study will include patients meeting DSM-IV-TR criteria for dementia of Alzheimer's type, and age- and gender-matched healthy control subjects meeting criteria of normal neurological function.

You may qualify if:

• Subject has been diagnosed with dementia of Alzheimer's type (DSM-IV-TR) or is serving as a healthy control subject with normal neurological function based on medical history and following neurological exam.
• AD Subject has a screen MMSE raw score \> 16 or HC subject has a screen MMSE raw score \> 26.
• Subject is between 50 and 90 years of age at the time of screening.
• Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
• Subject is a non-smoker.
• Subject is judged to be in good health other than AD, based on medical history and brief physical examination.
• AD subject has a care-giver or spouse who is willing and able to assure subject compliance with study procedures or subject is participating as a healthy control subject.

You may not qualify if:

• Subject has a history or diagnosis of a significant neurological condition other than Alzheimer's disease including Parkinson's disease, vascular dementia, Lewy body dementia, frontal temporal dementia, human immunodeficiency virus, multiple sclerosis, seizures, epilepsy, stroke, ADHD, dyslexia, or severe traumatic brain injury.
• Subject has a history of primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder, delusional disorder) or bipolar disorder.
• Subject has a Modified Hachinski Ischemia Scale (HIS) score greater than 4.
• The subject has a recent history (within 2 years) of alcohol or substance abuse/dependence.
• Subject had an MRI within two weeks prior to Study Day 1.
• Subject has metal dental braces, pacemaker or other common medical devices that may interfere with the MEG scan.
• Subject is unable to complete the MEG scan procedure.
• Investigator has any concern regarding the safe participation of a subject in the study, or if for any other reason the investigator considers the subject inappropriate for study participation.

Sponsors & Collaborators

• Orasi Medical, Inc.: lead

Study Sites (2)

Rush Alzheimer's Disease Center

Chicago, Illinois, 60612, United States

Location

Alexian Brothers Neuroscience Institute

Elk Grove Village, Illinois, 60007, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Concetta Forchetti, MD, PhD

  Alexian Brothers Neuroscience Institute

  PRINCIPAL INVESTIGATOR

• Raj C Shah, MD

  Rush Alzheimer's Disease Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 4, 2009
• First Posted: September 9, 2009
• Study Start: September 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: August 13, 2010

Record last verified: 2010-08

Locations

US (2)