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NCT00766363 · ClinicalTrials.gov registry record · Phase 1

Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Alzheimer's Disease

A Phase 1 study, sponsored by FORUM Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
49
Enrollment target

NCT00766363 is a Phase 1 study that has completed, run by FORUM Pharmaceuticals. The registered enrollment target is 49 participants.

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The verdict

NCT00766363, a Phase 1 study, has completed, sponsored by FORUM Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
49 participants
Enrollment target

Study Summary

This study is being conducted to determine the safety, tolerability, and pharmacokinetics (PK) of three different doses of an investigational medication, EVP-6124, in individuals with mild to moderate Alzheimer's disease who are also taking an Alzheimer's medication (AChEI \[acetylcholinesterase inhibitor\]: either donepezil or rivastigmine). In addition, PK of AChEI medications will be assessed. Cognitive function will be evaluated on an exploratory basis.

Interventions

  • DRUG Donepezil
  • DRUG EVP-6124 (0.1 mg/day)
  • DRUG EVP-6124 (0.3 mg/day)
  • DRUG EVP-6124 (1.0 mg/day)
  • DRUG Comparator: Placebo

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2008-10
Est. Completion 2009-03
Phase Phase 1

Sponsor

FORUM Pharmaceuticals

13 total trials

What the Registry Record Tells You About NCT00766363

The ClinicalTrials.gov registry entry for NCT00766363 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is FORUM Pharmaceuticals, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Donepezil is the first listed.

NCT00766363 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00766363 about?

NCT00766363 is a clinical study titled "Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Alzheimer's Disease". This study is being conducted to determine the safety, tolerability, and pharmacokinetics (PK) of three different doses of an investigational medication, EVP-6124, in individuals with mild to moderate Alzheimer's disease who are also taking an Alzheimer's medication (AChEI \[acetylcholinesterase inh...

What is the current status of trial NCT00766363?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2008-10. Estimated completion is 2009-03.

What interventions are being tested in trial NCT00766363?

The interventions under investigation include: Donepezil (DRUG), EVP-6124 (0.1 mg/day) (DRUG), EVP-6124 (0.3 mg/day) (DRUG), EVP-6124 (1.0 mg/day) (DRUG), Comparator: Placebo (DRUG).

Who is sponsoring clinical trial NCT00766363?

This trial is sponsored by FORUM Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.