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TerminatedPhase 4Results posted

The CIRCADIAN Study: Evaluation of Modulating Effect of Galantamine on Circadian Rhythm in Patients With Mild to Moderate Alzheimer's Disease

Phase IV Study for the Assessment of Modulating Effect of Galantamine (Reminyl PRC) on Circadian Rhythm in Patients With Moderate Alzheimer's Disease

Lead sponsor

Janssen-Cilag, S.A.

Asset

Galantamine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 12-20•Study partner/caregiver required

Primary endpoint

•Sleep/Wake Patterns

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Eudract number2009-013689-18

Org study IDCR015586

Secondary IDGALALZ4041Janssen-Cilag S.A., Spain

NCT IDNCT01181921

Timeline

Milestones

Study first posted2010-08-13estimated

Study start2011-05 (month precision)

Primary completion2011-06actual (month precision)

Study completion2011-06actual (month precision)

Results first posted2012-08-14estimated

Last update posted2014-05-01estimated

Assets

Drug assets

Galantamine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Behavior / neuropsychiatric

2 endpoints

Primary/protocol endpoint

Change From Baseline in Sleep/Wake Patterns as Measured by Actigraph at 12 Weeks

Time frame:Baseline and 12 weeks

change from baseline, improvement

Primary/registry result

Change From Baseline in Sleep/Wake Patterns as Measured by Actigraph at 12 Weeks

Time frame:Baseline and 12 weeks

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.