HP Xenon-129 fMRI of Healthy Volunteers and Participants With Alzheimer's Disease

• Status: Unknown status
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study involves imaging participants' brains using MRI. The goal is to develop a high-resolution, high-sensitivity imaging tool, hyperpolarized xenon functional brain magnetic resonance imaging, which can provide more sensitive measurement of brain function, facilitating the development of drugs for more successful treatment of Alzheimer's disease.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Thunder Bay Regional Research Institute
• Collaborators: Lakehead University; St. Joseph's Care Group; Thunder Bay Regional Health Sciences Centre
• Treatments: Xenon

Criteria

Inclusion Criteria:

A participant is eligible for inclusion in the study if the individual meets all of the following criteria:

1. Self-reported proficiency in English language.

2. Equal to or more than 8 years of education.

3. Normal or corrected to normal vision.

4. Able to provide informed consent.

5. Able to hold their breath for 20 seconds.

Normal cognition for healthy participant group inclusion criteria:

1. Preserved independence in functional abilities.

2. MoCA score no less than 26.

3. Males and non-lactating females of 18 to 85 years of age.

Alzheimer's disease group inclusion criteria:

1. Participants meet National Institute on Aging-Alzheimer's Association for probable or possible Alzheimer's Disease dementia.

2. MoCA score no less than 16.

3. Males and non-lactating females of 60 to 85 years of age.

4. Have a family member, close friend, or LAR that can be present for the informed consent process and study visits.

Exclusion Criteria:

A participant is ineligible for the study if the individual meets any of the following criteria:

1. Serious underlying medical condition, other, then the condition being investigated, which may affect cognitive function of the participant (in the opinion of the investigator): substance abuse, psychotic or depressive disorder, advanced or poorly controlled cardiac, pulmonary, hepatic, renal, neurological disorders in which the patient has significant speech, visual, motor or cognitive deficit, seizure disorders, endocrine or infectious disease or active malignancy.

2. MRI incompatibility as determined by MR Technologist during MRI screening.

3. Self-identifies as claustrophobic.

4. Female exclusion only: Are or may be pregnant; Planning on becoming pregnant.

5. Is a student currently enrolled in a course at Lakehead University where the Principal Investigator (PI) is the instructor.

6. Is a student currently enrolled in a degree program at Lakehead University where the PI is their direct thesis supervisor.

7. Is currently an employee of the PI at the Thunder Bay Regional Research Institute (TBRRI) and/or Lakehead University.

Normal cognition group exclusion criteria:

1. History of diagnosed neurological disease or injury.

Alzheimer's disease group exclusion criteria:

1. Existing diagnosis of dementia of etiology other than Alzheimer's disease.

2. Acute Delirium on the day of scanning (CAM tool assessment)