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Safety and Tolerability Study of Extended Release (ER) Galantamine in Alzheimer's Disease - Article


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Clinical Trial: Safety and Tolerability Study of Extended Release (ER) Galantamine in Alzheimer's Disease

Safety and Tolerability Study of Extended Release (ER) Galantamine in Alzheimer’s Disease

This study is currently recruiting patients.

Sponsored by: Janssen Pharmaceutica
Information provided by: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

Purpose

The purpose of this study is to evaluate the safety and tolerability of an extended release formulation of the drug galantamine using a rapid dose escalation regimen.

Condition Treatment or Intervention Phase
Alzheimer's Disease
  Drug: galantamine ER
 Phase III

MedlinePlus related topics:  Alzheimer's Caregivers;   Alzheimer's Disease
Genetics Home Reference related topics:  Alzheimer disease

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety Study

Official Title: Galantamine ER Open Label Rapid Dose Escalation Trial in Alzheimer’s Disease

Further Study Details: 

Expected Total Enrollment:  100

Study start: May 2004;  Expected completion: November 2004

Eligibility

Ages Eligible for Study:  60 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Diagnosis of Alzheimer's Disease

Location and Contact Information


California
      California Neuroscience Research, Sherman Oaks,  California,  91403,  United States; Recruiting
Susie Tanamly  818-990-2671 
Thomas Shiovitz, MD,  Principal Investigator

      Institute on Aging Research Center, San Francisco,  California,  94118,  United States; Recruiting
Hazel Outlaw  415-750-4180  Ext. 177 
Richard Moore, MD,  Principal Investigator

Florida
      University of Florida Brain Institute, Gainsville,  Florida,  32611,  United States; Recruiting
Shelia O'Hara  352-392-3681 
Josepha Cheong, MD,  Principal Investigator

Hawaii
      John A Burns School of Medicine, Honolulu,  Hawaii,  96817,  United States; Recruiting
Dennis Shewell  808-523-8461 
Patricia L Blanchette, MD,  Principal Investigator

New Jersey
      Hunterdon Medical Center Senior Services, Flemington,  New Jersey,  08822,  United States; Recruiting
Jennifer Hamil  908-788-6373 
Sandra Siegel  909-788-6373 
Kumar Nanjagowder, MD,  Principal Investigator

Ohio
      Valley Medical Primary Care, Centerville,  Ohio,  45459,  United States; Recruiting
Debra McElhaney, MA  937-208-8282 
Meenakshi Patel, MD,  Principal Investigator

      Ohio State University Memory Disorders Clinic, Columbus,  Ohio,  43210,  United States; Recruiting
Jennifer Warner  614-293-8531 
Jennifer Knick  614-293-8531 
Douglas Scharre, MD,  Principal Investigator

Pennsylvania
      Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033,  United States; Recruiting
Peg DeLillis  717-531-7240 
Joan Busner  717-531-7240 
Paul Kettl, MD,  Principal Investigator

Rhode Island
      Butler Hospital, Providence,  Rhode Island,  02906,  United States; Recruiting
Margy Bowker, RN  401-455-6402 
Steven Salloway, MD,  Principal Investigator

South Carolina
      Medical University of South Carolina, Charleston,  South Carolina,  29406,  United States; Recruiting
Don Bagwell  843-740-1592  Ext. 12 
Warachal Faison, MD,  Principal Investigator

Tennessee
      Meharry Medical College, Nashville,  Tennessee,  37208,  United States; Recruiting
Joan Ross  615-327-6565 
Jerry Duncan, MD,  Principal Investigator

Texas
      Texas Tech University Health Sciences Center, Lubbock,  Texas,  79416,  United States; Recruiting
Margie Lance-Fish  806-743-2587 
Jimmy Garza  806-743-2587 
Randolph Schiffer, MD,  Principal Investigator

More Information

Study ID Numbers:  GAL-ALZ-303
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  May 12, 2004
ClinicalTrials.gov Identifier:  NCT00082602
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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Page Updated: June 1, 2005
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