Assessment of Cholinergic and Cognitive Function Using Pharmacologic ASL-Perfusion MRI

NCT01379001 | Completed

• 1 other identifier: K23AG031320
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cholinergic Function

Keywords

cholinergic function; aging; pharmacologic MRI

Outcome Measures

Primary Outcomes (1)

• Cerebral blood flow

  cerebral blood flow will be measured 3 hours after drug administration using Arterial spin-labeled perfusion MRI

  3 hours

Secondary Outcomes (1)

• cognitive performance

  4 hours

Study Arms (2)

Young

EXPERIMENTAL

Young healthy controls, aged 21-35

Drug: Scopolamine; Drug: Placebo

Older

EXPERIMENTAL

Older healthy controls, aged 65-80

Drug: Scopolamine; Drug: Placebo; Drug: Donepezil

Interventions

Scopolamine DRUG

Scopolamine 0.4mg IM x 1 dose; adjustment in older group for weight (0.4mg/70kg)

Older; Young

Placebo DRUG

IM or PO placebo

Older; Young

Donepezil DRUG

donepezil 5mg PO x 1

Also known as: Aricept

Older

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy volunteers

You may not qualify if:

• 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

Sponsors & Collaborators

• Hebrew SeniorLife: lead

MeSH Terms

Interventions

Scopolamine; Donepezil

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperidines; Heterocyclic Compounds, 1-Ring; Polycyclic Compounds

Study Officials

• Tamara Fong, MD

  Hebrew Rehabilitation Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Scientist/Assistant Professor of Neurology

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: June 23, 2011
• Study Start: July 1, 2008
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 4, 2013

Record last verified: 2013-01