Assessment of Cholinergic and Cognitive Function Using Pharmacologic ASL-Perfusion MRI
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ClinicalTrials.gov Identifier: NCT01379001 |
Recruitment Status :
Completed
First Posted : June 23, 2011
Last Update Posted : January 4, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cholinergic Function | Drug: Scopolamine Drug: Placebo Drug: Donepezil | Not Applicable |
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 |

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 |
- Cerebral blood flow [ Time Frame: 3 hours ]cerebral blood flow will be measured 3 hours after drug administration using Arterial spin-labeled perfusion MRI
- cognitive performance [ Time Frame: 4 hours ]participants will undergo cognitive testing following drug administration and MRI acquisition

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Ages Eligible for Study: | 21 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
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 |