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Efficacy and Safety of Ramelteon in Subjects With Mild to Moderate Alzheimer's Disease

NCT00325728 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2017-08-14

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy of ramelteon, once daily (QD), in subjects with mild to moderate Alzheimer's Disease and sleep disturbance

Conditions

  • Chronic Insomnia

Interventions

DRUG

Ramelteon

Ramelteon 8mg, tablets, orally, once nightly for up to 8 weeks.

DRUG

Placebo

Ramelteon placebo matching tablets, orally, once nightly for up to 8 weeks.

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda Global Research and Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-21
Primary Completion
2007-08-01
Completion
2007-08-20

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00325728 on ClinicalTrials.gov