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Study of the Safety & Efficacy of GM-CSF (Leukine) in the Treatment of Alzheimer's Disease

This study is currently recruiting participants.
Verified July 2012 by University of South Florida
Sponsor:
Collaborator:
The Dana Foundation
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01409915
First received: August 2, 2011
Last updated: July 16, 2012
Last verified: July 2012
History of Changes
  Purpose

A medicine that is FDA-approved for bone marrow stimulation (called Leukine) will be tested for its ability to be tolerated by Alzheimer's disease patients and potentially to improve their memory.


Condition Intervention Phase
Alzheimer's Disease
 Drug: Sagramostim
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Phase 2 Trial of the Safety & Efficacy of GM-CSF (Leukine) in the Treatment of Alzheimer's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Ability of AD subjects to tolerate Leukine treatment will be assessed [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Various tests of well being and toxicity will be monitored for 6 months after treatment


Secondary Outcome Measures:
  • Ability of Leukine treatment to improve cognition of AD subjects [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Neuropsychological measures will be assessed at various intervals up to 6 months following treatment (or placebo)


Estimated Enrollment: 40
Study Start Date: March 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Leukine
5 subjects 120 mcg /m2/day Leukine subcutaneously for 5 days/week for three weeks. DSMB will then review data and recommend whether to continue at the same dos or double it to current recommended dose for additional subjects
 Drug: Sagramostim
5 subjects 120 mcg /m2/day Leukine subcutaneously for 5 days/week for three weeks. DSMB will then review data and recommend whether to continue at the same dos or double it to current recommended dose for additional subjects
Other Names:
  • Leukine
  • GM-CSF

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age 55 or older
  2. should have a mild to moderate AD diagnosis (MMSE 10-26 inclusive)
  3. if on anti-dementia treatment should be on stable treatment for at least 2 months (ie cholinesterase inhibitor and/or Memantine or Axona)
  4. should be fluent in English,
  5. should be be physically able to participate by medical history, clinical exam and tests,
  6. should have a study partner to accompany them to scheduled visits.

Exclusion Criteria:

  1. clinically relevant arrythmias,
  2. a resting pulse less than 50,
  3. active cancer other than non melanoma skin cancers,
  4. use of another investigatory drug within 2 months of screening,
  5. significant stroke or head trauma by history or MRI
  6. Contraindication for having a MRI
  7. DSMIV criteria for a current major psychiatric disorder, and
  8. sensitivity to yeast or yeast products.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409915

Contacts
Contact: Ashok Raj, MD 813-396-0606 braj@health.usf.edu

Locations
United States, Florida
USF Byrd Alzheimer's Institute Recruiting
Tampa, Florida, United States, 33613
Principal Investigator: Ashok Raj, MD            
Sponsors and Collaborators
University of South Florida
The Dana Foundation
  More Information

No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01409915     History of Changes
Other Study ID Numbers: Pro00002098
Study First Received: August 2, 2011
Last Updated: July 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of South Florida:
Alzheimer's disease
neuropsychological assessment
GM-CSF
Leukine

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013