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NCT01100775 · ClinicalTrials.gov registry record · Phase 2

Effects of Galantamine on Cognition

A Phase 2 study, sponsored by University of Maryland, Baltimore.

Completed
Registry status
Phase 2
Development phase
12
Enrollment target

NCT01100775: Completed Phase 2 study, sponsored by University of Maryland, Baltimore.

NCT01100775 is a Phase 2 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01100775, a Phase 2 study, has completed, sponsored by University of Maryland, Baltimore.

COMPLETED
Registry status
Phase 2
Development phase
12 participants
Enrollment target

Study Summary

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.

Primary Outcome

Rapid Visual Information Processing (RVIP) measures primarily sustained attention but perhaps also working memory. The task was continuous stimuli presentation of a stream of single digits (from 1 to 9) presented in the center of the computer monitor at a rate of 1/600milliseconds; the subjects respond when the they see a target sequence of 3 odds or 3 evens in consecutive sequence. Two target sequences are separated by a minimum and maximum of 30 non-target digits.

Interventions

  • DRUG Placebo
  • DRUG Galantamine

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2010-05
Est. Completion 2014-08-21
Phase Phase 2
University of Maryland, Baltimore

560 total trials

What the finished NCT01100775 record still lists

NCT01100775 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01100775 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01100775 about?

NCT01100775 is a clinical study titled "Effects of Galantamine on Cognition". 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 relati...

What is the current status of trial NCT01100775?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2010-05. Estimated completion is 2014-08-21.

What interventions are being tested in trial NCT01100775?

The interventions under investigation include: Placebo (DRUG), Galantamine (DRUG).

Who is sponsoring clinical trial NCT01100775?

This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01100775's enrollment target sits among peer trials

12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01100775, the US trial registry maintained by the National Library of Medicine. NCT01100775 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.