Completed PHASE2 INTERVENTIONAL 2-arm NCT00325728

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

A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of 8 Week Treatment of Rozerem 8 mg (QHS) in Sleep Disturbed, Mild to Moderately Severe Alzheimer's Disease Subjects

Sponsor: Takeda

Conditions Chronic Insomnia

Interventions Placebo Ramelteon

Updated 8 times since 2017 Last updated: Aug 10, 2017 Started: Mar 21, 2006 Primary completion: Aug 1, 2007 Completion: Aug 20, 2007

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Chronic Insomnia and is currently completed. Takeda leads this study, which shows 8 recorded versions since 2006 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

8 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE2
Sep 2024 — Sep 2025 [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Jan 2021 — Jul 2024 [monthly]

Completed PHASE2
Jun 2018 — Jan 2021 [monthly]

Completed PHASE2

▶ Show 3 earlier versions

Sep 2017 — Jun 2018 [monthly]

Completed PHASE2
Feb 2017 — Sep 2017 [monthly]

Completed PHASE2
Jan 2017 — Feb 2017 [monthly]

Completed PHASE2

First recorded

Mar 2006

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Takeda

Data source: Takeda

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Alabaster, United States , Albuquerque, United States , Atlanta, United States , Beaufort, United States , Bellaire, United States , Bennington, United States , Boston, United States , Boynton Beach, United States , Bradenton, United States , Brooklyn, United States and 62 more locations