NCT00369603

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 29, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

April 11, 2013

Status Verified

June 1, 2008

Enrollment Period

1 year

First QC Date

August 28, 2006

Last Update Submit

April 9, 2013

Conditions

Alzheimer's Disease

Keywords

Alzheimer's DiseasefMRIFunctional NeuroimagingAllosteric Nicotinic Receptor ModulationAcetylcholinesterase InhibitionHead to headDose escalationBiomarker

Outcome Measures

Primary Outcomes (1)

  • 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.

    4-weeks and 12-weeks

Secondary Outcomes (1)

  • Differences in cognitive testing and functional status at pre-treatment baseline and after completion of the 12-week treatment trial.

    baseline and 12-weeks

Study Arms (2)

Razadyne ER

EXPERIMENTAL

galantamine treatment group

Drug: Razadyne ER

Aricept

EXPERIMENTAL

Aricept Treatment Group

Drug: Aricept

Interventions

Razadyne ERDRUG

4-weeks 8mg. Razadyne ER, then 4-weeks 16mg. Razadyne ER, and a subsequent 4-weeks of 24mg. Razadyne ER

Razadyne ER
AriceptDRUG

8-weeks 5mg. Aricept and a subsequent 4-weeks of 10mg. Aricept

Aricept

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joseph & Kathleen Bryan Alzheimer's Disease Research Unit

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

GalantamineDonepezil

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Amaryllidaceae AlkaloidsAlkaloidsHeterocyclic CompoundsBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingPolycyclic Compounds

Study Officials

  • Jeffrey N Browndyke, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

  • Roberto Cabeza, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

  • James R Burke, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

  • Kathleen Welsh-Bohmer, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2006

First Posted

August 29, 2006

Study Start

October 1, 2006

Primary Completion

October 1, 2007

Study Completion

November 1, 2007

Last Updated

April 11, 2013

Record last verified: 2008-06

Locations

US(1)