The CIRCADIAN Study: Evaluation of Modulating Effect of Galantamine on Circadian Rhythm in Patients With Mild to Moderate Alzheimer's Disease
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer Disease | Drug: Galantamine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1 participants |
Allocation: | N/A |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Galantamine |
Drug: Galantamine
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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of Alzheimer-type dementia according to the definition of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV-TR) and a diagnosis of possible or probable Alzheimer-type dementia, according to NINCDS-ADRDA classification (American Psychiatric Association, 2000
- McKhann, G. et al, 1984)
- should have moderate dementia, evidenced by a Mini-Mental Status examination (MMSE) score between 12 and 20, including these limits
- At inclusion, a recent CT or MRI must be available
- Physical examination and the electrocardiogram (ECG) performed at the screening visit must be normal or consistent with the underlying illness in the study population
- History of sleep behavior changes (eg: insomnia, daytime sleepiness, changes in sleep/wakefulness cycle) 2 or more weeks before, reported by the caregiver
- Patients should have a caregiver sufficiently informed of their condition and, if possible, living with them
- Patients (or their legally-acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Exclusion Criteria:
- History of other neurodegenerative disorders, such as Parkinson's disease, Pick disease or Huntington's chorea, Down syndrome, Creutzfeldt-Jakob disease (patients with mild extrapyramidal signs for which no treatment is required are not excluded from the trial)
- Clinically significant cardiovascular disease expected to limit the ability of the patient to participate and complete the study
- Any history of epilepsy or seizures (except for febrile seizures in childhood)
- Clinically significant psychiatric condition, according to the DSM-IV criteria, particularly major depression or schizophrenia currently
- Active peptic ulcer (treatment of the disease started < 3 months or treatment is not successful
- Clinically significant liver, renal, pulmonary, metabolic, or endocrine disorders
- Clinically significant urinary flow obstruction
- History of or suspected alcoholism or drug abuse in accordance to the DSM-IV criteria, in the past year, or previous history of prolonged abuse
- Previous therapy with memantine or an acetylcholinesterase inhibitor (including galantamine)
- Patients receiving antipsychotics, hypnotic or sedative agents (those patients who need this kind of medication during the study would be withdrawn from the study and replaced)
- Bedridden patients

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
Spain | |
Barcelona, Spain |
Study Director: | Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial | Janssen-Cilag, S.A. |
Responsible Party: | Janssen-Cilag, S.A. |
ClinicalTrials.gov Identifier: | NCT01181921 |
Other Study ID Numbers: |
CR015586 GALALZ4041 ( Other Identifier: Janssen-Cilag S.A., Spain ) 2009-013689-18 ( EudraCT Number ) |
First Posted: | August 13, 2010 Key Record Dates |
Results First Posted: | August 14, 2012 |
Last Update Posted: | May 1, 2014 |
Last Verified: | April 2014 |
Alzheimer Disease Dementia Sleep Disorders Galantamine Reminyl |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Galantamine |
Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Parasympathomimetics Autonomic Agents Peripheral Nervous System Agents Nootropic Agents |