NCT01615666

Brief Summary

The purpose of this study is to use a functional MRI (fMRI) index to compare the brain activity of healthy volunteers to that of people with mild cognitive impairment (MCI) and Alzheimer's disease. The ultimate goal is to develop an early diagnostic tool for Alzheimer's disease. The study hypotheses are:

  1. 1.The fMRI index will differentiate between Alzheimer's disease, non-Alzheimer's dementia, and healthy volunteers;
  2. 2.The fMRI index will distinguish participants with MCI who convert to Alzheimer's disease from those who convert to a non-Alzheimer's dementia and those who remain stable;
  3. 3.MCI participants with a lower fMRI index at baseline who convert will progress to Alzheimer's sooner than those with a higher fMRI index, and MCI participants with a faster rate of fMRI index decline who convert will have an earlier onset of Alzheimer's disease.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

March 1, 2009

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 14, 2016

Status Verified

January 1, 2016

Enrollment Period

6.8 years

First QC Date

June 6, 2012

Last Update Submit

January 13, 2016

Conditions

Alzheimer's DiseaseMild Cognitive ImpairmentFrontotemporal Dementia

Keywords

Alzheimer's diseaseMild Cognitive ImpairmentFrontotemporal dementiafMRIfunctional neuroimagingMemory

Outcome Measures

Primary Outcomes (1)

  • To determine the sensitivity and specificity of the MRN Index as an AD biomarker.

    5 years

Study Arms (5)

Healthy volunteers

Healthy volunteers who will undergo functional MRI (fMRI) to obtain fMRI index

Alzheimer's disease

Individuals with Alzheimer's disease who will undergo functional MRI (fMRI) to obtain fMRI index

Non-Alzheimer's dementia

Individuals with Non-Alzheimer's dementia who will undergo functional MRI (fMRI) to obtain fMRI index

Amnestic mild cognitive impairment

Individuals with Amnestic mild cognitive impairment who will undergo functional MRI (fMRI) to obtain fMRI index

Nonamnestic mild cognitive impairment

Individuals with Nonamnestic mild cognitive impairment who will undergo functional MRI (fMRI) to obtain fMRI index

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Alzheimer's, non-Alzheimer's dementia, and mild cognitive impairment (MCI) participants recruited from the Medical College of Wisconsin/Froedtert Hospital Memory Disorders Clinic * MCI and healthy volunteers recruited from the community

You may qualify if:

  • years of age or older (50 years of age or older for frontotemporal dementia patients)
  • Normal memory, mild cognitive impairment (memory loss that does not significantly affect normal daily activities), or clinical diagnosis of Alzheimer's disease or frontotemporal dementia (includes primary progressive aphasia)
  • Right-handed
  • General good physical health

You may not qualify if:

  • History of stroke or neurological disease (other than Alzheimer's disease or frontotemporal dementia)
  • Seizures or head injury with loss of consciousness within the last five years
  • Ferrous (magnetic) or electronic implants (due to the magnet in the MRI scanner)
  • Claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Wisconsin/Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Buccal (cheek) swab

MeSH Terms

Conditions

Alzheimer DiseaseCognitive DysfunctionFrontotemporal Dementia

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition DisordersFrontotemporal Lobar DegenerationTDP-43 ProteinopathiesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Shi-Jiang Li, PhD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2012

First Posted

June 8, 2012

Study Start

March 1, 2009

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 14, 2016

Record last verified: 2016-01

Locations

US(1)