search
Back to results

MRI of Alzheimer's Disease Imaging Amyloid Plaques in Persons With and Without Memory Problems

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Alzheimer's Disease focused on measuring MRI, Alzheimer Disease, Amyloid, AD, Healthy Volunteer, HV

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers
  • INCLUSION CRITERIA:
  • Any neurologically and psychiatrically normal, male or female, healthy volunteer ages 55-90 years old. Participants must be capable of understanding the procedures and requirements of this study and subjects must be willing to sign an informed consent document. Normal controls will demonstrate normal function in daily life, based on the Clinical Dementia Rating Scale (CDR). The CDR is administered annually to all JHADRC participants.
  • AD patients will be required to meet the NINCDS/ADRDA criteria for AD. All patients must be mildly impaired. Severity will be measured by the Mini-Mental State Exam (MMSE) and only patients with an MMSE score of 20 - 26 will be included. They must be able to give informed consent.

EXCLUSION CRITERIA:

  • Inability to cooperate.
  • A subject will be excluded if he/she has a contraindication to MR scanning such as the following: claustrophobia, pregnancy, aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or auto-defibrillator; cochlear implant; ocular foreign body (e.g. metal shavings) or insulin pump.
  • Subjects who underwent brain surgery, or other neurological disease (e.g., stroke, Parkinson's disease, significant brain vascular disease, brain trauma).
  • Evidence of cerebrovascular risk factors, including diabetes, arrhythmias, and lacunar infarcts seen on MRI.
  • History of vertigo, seizure disorder, middle-ear disorder, and double vision.
  • Active major psychiatric illness.
  • Dental work such as ferromagnetic crowns or bridges.

Sites / Locations

  • Johns Hopkins University
  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 19, 2006
Last Updated
June 30, 2017
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
search

1. Study Identification

Unique Protocol Identification Number
NCT00413621
Brief Title
MRI of Alzheimer's Disease Imaging Amyloid Plaques in Persons With and Without Memory Problems
Official Title
MRI of Alzheimer's Disease Imaging Amyloid Plaques in Persons With and Without Memory Problems
Study Type
Observational

2. Study Status

Record Verification Date
October 7, 2009
Overall Recruitment Status
Completed
Study Start Date
December 14, 2006 (undefined)
Primary Completion Date
October 7, 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

Brief Summary
The study will investigate the possibility of detecting early signs of Alzheimer's disease using magnetic resonance imaging (MRI). If plaques, types of damage, can be imaged by MRI, the procedure could be used in clinical trials and may also help in the clinical diagnosis of patients. Alzheimer's disease, a progressive disease, is a major cause of functional disability and institutionalization, affecting 4.5 million people in the United States, a number that will more than triple by 2030 as the population ages. Patients ages 55 to 90 who have mild symptoms of Alzheimer's disease and who are in good health may be eligible for this study. Twenty patients will be recruited from Johns Hopkins' Alzheimer's Disease Research Center. There will also be a control group of 20 people without the disease. Healthy patients and volunteers will have a clinical MRI brain scan and a neurological examination at Johns Hopkins Hospital before the 7T MRI scan. Also, patients will have a Mini-Mental State Examination, a standardized test to evaluate memory, done at Johns Hopkins within 4 weeks of the 7T MRI. This study uses a device situated at the NIH Bethesda campus that operates at a high magnetic field strength of 7 Tesla, that is, the unit used to measure the strength of a strong magnet. The Food and Drug Administration has categorized MRI up to 8 Tesla as not a significant health risk. MRI scanning is routinely done at magnetic field strengths up to 4T. MRI images are created through the use of a large magnet and radio waves. During the procedure, patients lie on a table moved into a strong magnetic field. They are asked to lie still but can easily hear and speak to research staff. A respiratory belt is placed around the chest, and a finger probe is placed on the finger, to monitor breathing and heart rate. For obtaining a better picture, a special lightweight coil may be placed on or around the patient's head. The scan takes from 20 minutes to 2 hours, with most scans at 45 to 90 minutes. Due to limited experience with the use of 7T MRI and its investigational nature, patients will be asked to complete a questionnaire immediately after the study. They will be asked about their comfort level and if they experienced unusual sensations. Answers will be reviewed with patients by an experienced MRI investigator to get details of any unusual sensations reported. If patients experience unusual sensations, they are followed up by phone within 24 hours. This study wi...
Detailed Description
Objective: The objective of the proposed pilot study is to investigate the possibility of detecting early signs of Alzheimer's Disease (AD) using high field (7T) MRI. If plaques can be imaged by MRI, the procedure could be used as a measure of efficacy in clinical trials of AD, and replace more invasive methods such as positron emission tomography (PET). This procedure might also be helpful in the clinical diagnosis of patients. Study Population: The target population is a group of 20 Alzheimer's patients with mild cognitive impairment. As reference, an age-matched control group (n=20) will be recruited from the normal adult population. Design: Our working hypothesis is that high resolution MRI at 7T allows detection of amyloid plaques in AD. To test this hypothesis, subjects from AD and control population will each undergo an MRI at 7T to image brain structure at high resolution. Brain cortical structures will then be compared between the two groups and investigated for abnormalities. Outcome Measure: As outcome measure of this study, it will be determined if (sub) cortical plaques typical of AD are detectable with high field MRI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
MRI, Alzheimer Disease, Amyloid, AD, Healthy Volunteer, HV

7. Study Design

Enrollment
40 (false)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA: Any neurologically and psychiatrically normal, male or female, healthy volunteer ages 55-90 years old. Participants must be capable of understanding the procedures and requirements of this study and subjects must be willing to sign an informed consent document. Normal controls will demonstrate normal function in daily life, based on the Clinical Dementia Rating Scale (CDR). The CDR is administered annually to all JHADRC participants. AD patients will be required to meet the NINCDS/ADRDA criteria for AD. All patients must be mildly impaired. Severity will be measured by the Mini-Mental State Exam (MMSE) and only patients with an MMSE score of 20 - 26 will be included. They must be able to give informed consent. EXCLUSION CRITERIA: Inability to cooperate. A subject will be excluded if he/she has a contraindication to MR scanning such as the following: claustrophobia, pregnancy, aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or auto-defibrillator; cochlear implant; ocular foreign body (e.g. metal shavings) or insulin pump. Subjects who underwent brain surgery, or other neurological disease (e.g., stroke, Parkinson's disease, significant brain vascular disease, brain trauma). Evidence of cerebrovascular risk factors, including diabetes, arrhythmias, and lacunar infarcts seen on MRI. History of vertigo, seizure disorder, middle-ear disorder, and double vision. Active major psychiatric illness. Dental work such as ferromagnetic crowns or bridges.
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16360788
Citation
Ferri CP, Prince M, Brayne C, Brodaty H, Fratiglioni L, Ganguli M, Hall K, Hasegawa K, Hendrie H, Huang Y, Jorm A, Mathers C, Menezes PR, Rimmer E, Scazufca M; Alzheimer's Disease International. Global prevalence of dementia: a Delphi consensus study. Lancet. 2005 Dec 17;366(9503):2112-7. doi: 10.1016/S0140-6736(05)67889-0.
Results Reference
background
PubMed Identifier
12925369
Citation
Hebert LE, Scherr PA, Bienias JL, Bennett DA, Evans DA. Alzheimer disease in the US population: prevalence estimates using the 2000 census. Arch Neurol. 2003 Aug;60(8):1119-22. doi: 10.1001/archneur.60.8.1119.
Results Reference
background
PubMed Identifier
10430421
Citation
Breitner JC, Wyse BW, Anthony JC, Welsh-Bohmer KA, Steffens DC, Norton MC, Tschanz JT, Plassman BL, Meyer MR, Skoog I, Khachaturian A. APOE-epsilon4 count predicts age when prevalence of AD increases, then declines: the Cache County Study. Neurology. 1999 Jul 22;53(2):321-31. doi: 10.1212/wnl.53.2.321. Erratum In: Neurology 2000 Jul 12;55(1):161-2.
Results Reference
background

Learn more about this trial

MRI of Alzheimer's Disease Imaging Amyloid Plaques in Persons With and Without Memory Problems

We'll reach out to this number within 24 hrs