The CIRCADIAN Study: Evaluation of Modulating Effect of Galantamine on Circadian Rhythm in Patients With Mild to Moderate Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT01181921|
Recruitment Status : Terminated (The recruitment rate was very low (one screening failure and one early withdrawal patient))
First Posted : August 13, 2010
Results First Posted : August 14, 2012
Last Update Posted : May 1, 2014
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Drug: Galantamine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Phase IV Study for the Assessment of Modulating Effect of Galantamine (Reminyl PRC) on Circadian Rhythm in Patients With Moderate Alzheimer's Disease|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
U.S. FDA Resources
Type= range, unit= mg, number= 8-24, form= capsule, route= oral use. The starting dose will be 8 mg/day for 4 weeks. Subsequently, the initial maintenance dose will be 16 mg/day for 4 weeks. Then, an increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment.
- Change From Baseline in Sleep/Wake Patterns as Measured by Actigraph at 12 Weeks [ Time Frame: Baseline and 12 weeks ]Actigraph is a small portable device that is worn on the wrist of the non-dominant arm to measure body movement during long time periods. It creates a pattern based on activity that is useful in assessing sleep-wake cycles across many consecutive days and nights. It is useful for assessing sleep phase disorders.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181921
|Study Director:||Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial||Janssen-Cilag, S.A.|