The CIRCADIAN Study: Evaluation of Modulating Effect of Galantamine on Circadian Rhythm in Patients With Mild to Moderate Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: Galantamine
Intervention description: 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.
Intervention MeSH terms: Galantamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Alzheimer Disease; Dementia; Sleep Disorders; Galantamine; Reminyl

Summary:

      The purpose of this study is to assess the modulating effect of galantamine on circadian
      rhythm in patients with moderate Alzheimer's disease.
    

Eligibility criteria:

        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