Effects of Galantamine on Cognition

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Maryland
Sponsor:
Collaborator:
Information provided by (Responsible Party):
MPRC, University of Maryland, Baltimore County
ClinicalTrials.gov Identifier:
NCT01100775
First received: January 4, 2010
Last updated: August 21, 2013
Last verified: August 2013
  Purpose

Schizophrenia is a chronic disorder with onset of psychosis occurring in late teen early twenties, with cognitive impairments and negative symptoms frequently emerging much earlier. Such cognitive impairments and negative symptoms but much milder are also observed in high-risk groups (such as relatives of schizophrenia patients), who may or may not develop the full blown psychotic disorder. Our study plans to recruit such non-ill subjects to test the effects of galantamine on clinical/physiological/cognitive measures. This study serves several goals: If a drug is found effective in treating subtle deficits, then it will provide treatment strategy in individuals with schizophrenia spectrum personality disorders and for early intervention in schizophrenia. In addition, one of the difficulties of testing a drug on schizophrenia is that patients take other medications (i.e., antipsychotic drugs) that can change the effects of the test drug. The proposed study will be in subjects who will not be taking antipsychotic medications. Our study will be carried out in two sessions, at least one month apart. Subjects will be randomly assigned to the two possible order of administration: the drug and then placebo, or the placebo and then drug. Subjects will be given a lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing. We will administer a battery of clinical/cognitive/neurophysiological tests after the 8 mg drug dose.


Condition Intervention Phase
Schizophrenia
Drug: Galantamine
Drug: Galantamine or Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: Effects of Galantamine on Cognition

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Determine effect of drug on cognition [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    The study will test whether the drug improves cognition (such as memory and attention) within few hours of taking the drug)


Secondary Outcome Measures:
  • Determine the effect of the drug on ability to express or experience emotions [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    We will test the effects of the drug on negative symptoms that include difficulty experiencing or expressing emotions, decreased social drive and decreased motivation.


Estimated Enrollment: 24
Study Start Date: May 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Galantamine
Drug: Galantamine
A lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing.
Other Names:
  • Razadyne
  • 01RZ437
Placebo Comparator: Placebo
Subjects will be randomly assigned to the two possible order of administration: the drug and then placebo, or the placebo and then drug.
Drug: Galantamine or Placebo
Subjects will be randomly assigned to the two possible order of administration: the drug and then placebo, or the placebo and then drug. Subjects will be given a lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age range of 18-64 (confirmed by drivers license or other form of identification)
  • the presence of 3 or more SSP symptoms (at least 2 of the SSP symptoms will be negative symptoms as defined by the schizoid traits)
  • the presence of visuospatial working memory impairment as defined by error in the oculomotor delayed response (ODR) task of more than 0.5 SD above the mean values in healthy control subjects
  • relative of an individual with schizophrenia, schizoaffective disorder, or schizophreniform disorder
  • able to provide written informed consent (ESC score 10 or above)

Exclusion Criteria:

  • subjects meeting criteria for a life-time diagnosis of any one of the DSM IV, Axis I psychotic disorders (exceptions being a single past episode of major depressive disorder with psychotic features or psychotic symptoms associated with substance abuse with the substance abuse ending 6-months prior to study participation) (this is for the SSP recruitment)
  • subjects meeting DSM-IV criteria for current alcohol or substance dependence (other than nicotine) within the last 6 months or DSM-IV criteria for alcohol or substance abuse (other than nicotine) within the last month
  • medical conditions that preclude participation in drug trials or assessments of outcome measures (including significant brain, cardiac, liver, lung, endocrinological or metabolic disorders)
  • received any investigational drug in the preceding four weeks
  • pregnant or of childbearing age and not using a medically approved form of birth control
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100775

Contacts
Contact: Matt Glassman 410-402-6827 mglassman@mprc.umaryland.edu
Contact: Dawn Detamore 410-402-6820 ddetamor@mprc.umaryland.edu

Locations
United States, Maryland
University of Maryland, Baltimore Recruiting
Baltimore, Maryland, United States, 21228
Contact: Matt Glassman    410-402-6827    mglassman@mprc.umaryland.edu   
Contact: Dawn Detamore, 1    410-402-6820    ddetamor@mprc.umaryland.edu   
Sub-Investigator: Elliot Hong, M.D.         
Sub-Investigator: Ikwunga Wonodi, M.D.         
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: L. E. Hong, M.D. University of Maryland, Baltimore County
  More Information

No publications provided

Responsible Party: MPRC, L. Elliot Hong, M.D., University of Maryland, Baltimore County
ClinicalTrials.gov Identifier: NCT01100775     History of Changes
Other Study ID Numbers: HP-00044959, 1P50MH082999-01
Study First Received: January 4, 2010
Last Updated: August 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Galantamine
Schizophrenia
working memory
cognitive

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Galantamine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 14, 2014