Functional Brain Imaging of Medication Treatment Response in Mild Alzheimer's Disease Patients

April 9, 2013 updated by: Duke University

Functional Neuroimaging (fMRI) Biomarker of Allosteric Nicotinic Receptor Modulation in Mild Alzheimer's Disease Patients: A Razadyne vs. Aricept Dose Escalation Trial

The purpose of this study is to determine whether standard medications approved for Alzheimer's disease treatment differ in their action on brain functioning and whether any observed brain activity differences as result of treatment are associated with particular patterns of dementia improvement or reduced decline.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study seeks to differentiate task-related and resting brain activity patterns captured via functional magnetic resonance imaging (fMRI) and associated with two common Alzheimer's disease (AD) medications, equivalent in acetylcholinesterase inhibition effect (AChEI) but differing with respect to allosteric nicotinic receptor modulation effect. It is the primary aim of this project to gain a better understanding of the brain mechanisms involved in the attentional and executive skills improvements associated with nicotinic receptor modulation in mild AD patients.

To address this question, this 12-week continuous treatment, double-blind, head-to-head dose-escalation treatment trial seeks to visualize any treatment response unique to allosteric nicotinic receptor modulation and to associate these fMRI data with standard cognitive assessment outcomes. Using in-scanner tasks shown to reliably elicit brain activity in cortical regions important to memory and attention, this treatment trial will examine both resting and task-related BOLD signal characteristics in a well-characterized sample of 36 mild AD patients after periods of low dose and high dose AD dementia treatment with either galantamine hydrobromide (AChEI + nicotinic receptor modulation) or donepezil hydrochloride (AChEI only). Both the low and high dose imaging comparisons between treatment groups will be equivalent for 35% AChEI-effect, which may allow for the isolation of BOLD signal unique to allosteric nicotinic receptor modulation in both brain at rest and task-related brain states.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Joseph & Kathleen Bryan Alzheimer's Disease Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must meet diagnosis of mild Alzheimer's disease
  • Must have a family member or caregiver who is willing to attend all study visits and provide information on your participation in the study
  • If female, must be post-menopausal
  • Must be able to swallow tablets

Exclusion Criteria:

  • Metal implants or medical devises unsafe for MRI use
  • Pre-menopausal female
  • HIstory of recent head injury
  • Significant major, life-threatening illness or injury (e.g., stroke, AIDS, etc.)
  • Vascular dementia or any dementia other than Alzheimer's Disease
  • History of significant alcoholism or drug abuse
  • History of seizure disorder, developmental delay or major psychiatric illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Razadyne ER
galantamine treatment group
Drug: Razadyne ER
4-weeks 8mg. Razadyne ER, then 4-weeks 16mg. Razadyne ER, and a subsequent 4-weeks of 24mg. Razadyne ER
Experimental: Aricept
Aricept Treatment Group
Drug: Aricept
8-weeks 5mg. Aricept and a subsequent 4-weeks of 10mg. Aricept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Brain activity patterns, as collected via functional magnetic resonance imaging (fMRI), at rest and associated with task performance after 4 weeks of low-dose treatment and after 8-weeks of higher-dose treatment.
Time Frame: 4-weeks and 12-weeks
4-weeks and 12-weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Differences in cognitive testing and functional status at pre-treatment baseline and after completion of the 12-week treatment trial.
Time Frame: baseline and 12-weeks
baseline and 12-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Ortho-McNeil Neurologics, Inc.

Investigators

  • Principal Investigator: Jeffrey N Browndyke, PhD, Duke University
  • Principal Investigator: James R Burke, PhD, Duke University
  • Principal Investigator: Kathleen Welsh-Bohmer, PhD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

August 28, 2006

First Submitted That Met QC Criteria

August 28, 2006

First Posted (Estimate)

August 29, 2006

Study Record Updates

Last Update Posted (Estimate)

April 11, 2013

Last Update Submitted That Met QC Criteria

April 9, 2013

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00011149
  • GAL-EMR-4026 (Other Identifier: DUMC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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