Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100165
Status:
COMPLETED
Last Update Posted:
2020-01-29
First Post:
2004-12-23
Brief Title:
Phase 2 Trial of a Nicotinic Agonist in Schizophrenia
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Phase 2 Trial of the Nicotinic Agonist 3-24 Dimethoxybenzylidene Anabaseine in Schizophrenia
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DMXB-A
Brief Summary:
The study hypothesis is that 3-24 dimethoxybenzylidene anabaseine DMXB-A an orally administered nicotinic cholinergic agonist will improve attention and other neuropsychological dysfunctions in schizophrenia leading to improved psychosocial outcome
Detailed Description:
The objective of the trial is to determine if dosing 3-24 dimethoxybenzylidene anabaseine twice daily for 4 weeks will improve cognition and be safe Secondary goals are to determine if these neurocognitive effects also have effects on neurobiological paradigms previously shown to be responsive to nicotinic receptor stimulation suppression of P50 auditory evoked response saccadic intrusions during smooth pursuit eye movements and hemodynamic activity in the hippocampus during smooth pursuit eye movements as measured by functional magnetic resonance imaging The purpose of these neurobiological measures is to assess whether the response to 3-24 dimethoxybenzylidene anabaseine is consistent with activation of nicotinic receptors In addition the investigators will assess clinical response using a battery of clinical assessment scales and assessments of daily living functions The purpose of these assessments is to address the FDA requirement of a clinical effect beyond change in laboratory neuropsychological performance This study and the subsequent two studies will also include assessments of the safety of 3-24 dimethoxybenzylidene anabaseine and related compounds
The purpose of the trial is to lay the groundwork for Phase III investigation If this trial finds that 3-24 dimethoxybenzylidene anabaseine has effects at a safe dose without tachyphylaxis then the investigators intend to proceed to a Phase III trial where the clinical importance of this effect can be measured
The trial will be a double blind trial with placebo control The order of doses and placebo will be randomized
The Phase 1 study was completed in January 2005 with 12 non-smoking schizophrenics subjects The subjects were concurrently treated with neuroleptics throughout the study They received 3 treatments each for 1 day in a double-blind crossover design The treatments were 3-24 dimethoxybenzylidene anabaseine 150 mg 75 mg 2 hours later 3-24 dimethoxybenzylidene anabaseine75 mg 375 mg 2 hours later and placebo A significant effect on neurocognition as measured by the Repeatable Battery for Assessment of Neuropsychological Status and on sensory gating as measured by P50 auditory evoked potentials was observed Subjects reported no significant symptoms One subjects white blood cell count decreased from just above normal limits on placebo to just below normal levels on 3-24 dimethoxybenzylidene anabaseine150 75 mg 2 hours later He did not receive further exposure to drug and his white blood cell count returned to normal at the next testing 2 days later
The purpose of the trial is to lay the groundwork for Phase III investigation If this trial finds that 3-24 dimethoxybenzylidene anabaseine has effects at a safe dose without tachyphylaxis then the investigators intend to proceed to a Phase III trial where the clinical importance of this effect can be measured
The trial will be a double blind trial with placebo control The order of doses and placebo will be randomized
The Phase 1 study was completed in January 2005 with 12 non-smoking schizophrenics subjects The subjects were concurrently treated with neuroleptics throughout the study They received 3 treatments each for 1 day in a double-blind crossover design The treatments were 3-24 dimethoxybenzylidene anabaseine 150 mg 75 mg 2 hours later 3-24 dimethoxybenzylidene anabaseine75 mg 375 mg 2 hours later and placebo A significant effect on neurocognition as measured by the Repeatable Battery for Assessment of Neuropsychological Status and on sensory gating as measured by P50 auditory evoked potentials was observed Subjects reported no significant symptoms One subjects white blood cell count decreased from just above normal limits on placebo to just below normal levels on 3-24 dimethoxybenzylidene anabaseine150 75 mg 2 hours later He did not receive further exposure to drug and his white blood cell count returned to normal at the next testing 2 days later
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| VISN 19 MIRECC | OTHER_GRANT | VA | None |