Assessment of Cholinergic and Cognitive Function Using Pharmacologic ASL-Perfusion MRI
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01379001 |
|
Recruitment Status :
Completed
First Posted : June 23, 2011
Last Update Posted : January 4, 2013
|
Sponsor:
Hebrew Rehabilitation Center, Boston
Information provided by (Responsible Party):
Tamara Fong, Hebrew Rehabilitation Center, Boston
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
This research study will look at how medications affect the pattern of blood flow in the brain. This study will use a special type of MRI (magnetic resonance imaging) scan called perfusion MRI to make measurements of cerebral (brain) blood flow. The medications we will use in this study are scopolamine (commonly used to treat motion sickness), mecamylamine (used to treat high blood pressure), and donepezil (used to treat memory loss). Cognitive testing will also be obtained, and correlated with the blood flow patterns in the brain.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cholinergic Function | Drug: Scopolamine Drug: Placebo Drug: Donepezil | Not Applicable |
Project Summary: This research project will investigate the value of combined pharmacologic manipulation and arterial spin-labeled perfusion MRI (pharmacologic ASL-pMRI) as an in vivo probe of cholinergic function. Methods to investigate cholinergic function in vivo are needed to better understand the role of acetylcholine in the physiology of the cerebral cortex, and in cognitive processes in health and in disease states. In this study, pharmacologic ASL-pMRI will be used to characterize the normal cerebral perfusion response to cholinergic manipulation in young healthy subjects. Cognitive measures will also be obtained and correlated with cerebral perfusion changes. Pharmacologic ASL-pMRI and cognitive testing will then be used to study how the cholinergic response is altered with normal aging and in delirium
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | Double (Participant, Investigator) |
| Official Title: | Assessment of Cholinergic and Cognitive Function Using Pharmacologic ASL-Perfusion MRI |
| Study Start Date : | July 2008 |
| Actual Primary Completion Date : | January 2013 |
| Actual Study Completion Date : | January 2013 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Young
Young healthy controls, aged 21-35
|
Drug: Scopolamine
Scopolamine 0.4mg IM x 1 dose; adjustment in older group for weight (0.4mg/70kg) Drug: Placebo IM or PO placebo |
|
Experimental: Older
Older healthy controls, aged 65-80
|
Drug: Scopolamine
Scopolamine 0.4mg IM x 1 dose; adjustment in older group for weight (0.4mg/70kg) Drug: Placebo IM or PO placebo Drug: Donepezil donepezil 5mg PO x 1
Other Name: Aricept |
Primary Outcome Measures :
- Cerebral blood flow [ Time Frame: 3 hours ]cerebral blood flow will be measured 3 hours after drug administration using Arterial spin-labeled perfusion MRI
Secondary Outcome Measures :
- cognitive performance [ Time Frame: 4 hours ]participants will undergo cognitive testing following drug administration and MRI acquisition
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 21 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- healthy volunteers
Exclusion Criteria:
- Any neurological condition, such as brain tumor, history of stroke, seizure disorder, attention deficit disorder, normal pressure hydrocephalus, dementia, traumatic brain injury
- Any major medical conditions, such a cancer, diabetes, glaucoma, prostate disease, uncontrolled hypertension
- antihistamine use
- tricyclic antidepressant use
- presence of metal in body, including pacemaker, defibrillator, neurostimulator, metal implants, or foreign metal objects such as bullets or shrapnel.
- anxiety or panic disorder
- history of claustrophobia
- pregnancy
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01379001
Sponsors and Collaborators
Hebrew Rehabilitation Center, Boston
Investigators
| Principal Investigator: | Tamara Fong, MD | Hebrew Rehabilitation Center |
| Responsible Party: | Tamara Fong, Assistant Scientist/Assistant Professor of Neurology, Hebrew Rehabilitation Center, Boston |
| ClinicalTrials.gov Identifier: | NCT01379001 History of Changes |
| Other Study ID Numbers: |
K23AG031320 ( U.S. NIH Grant/Contract ) |
| First Posted: | June 23, 2011 Key Record Dates |
| Last Update Posted: | January 4, 2013 |
| Last Verified: | January 2013 |
Keywords provided by Tamara Fong, Hebrew Rehabilitation Center, Boston:
|
cholinergic function aging pharmacologic MRI |
Additional relevant MeSH terms:
|
Donepezil Scopolamine Hydrobromide Butylscopolammonium Bromide Cholinergic Agents Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Physiological Effects of Drugs |
Nootropic Agents Adjuvants, Anesthesia Mydriatics Autonomic Agents Peripheral Nervous System Agents Cholinergic Antagonists Muscarinic Antagonists Parasympatholytics |