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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;  Study completion: November 2004

Eligibility

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

Criteria

Inclusion Criteria:


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
Record first received:  May 12, 2004
ClinicalTrials.gov Identifier:  NCT00082602
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10
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