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

NCT01181921 | Terminated Phase 4 Results

• 3 other identifiers: CR015586GALALZ40412009-013689-18
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer Disease

Keywords

Alzheimer Disease; Dementia; Sleep Disorders; Galantamine; Reminyl

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Sleep/Wake Patterns as Measured by Actigraph at 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.

  Baseline and 12 weeks

Study Arms (1)

Galantamine

EXPERIMENTAL

Drug: Galantamine

Interventions

Galantamine DRUG

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.

Galantamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag, S.A.: lead

Study Sites (1)

Unknown Facility

Barcelona, Spain

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Sleep Wake Disorders

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: COUNTRY MEDICAL DIRECTOR
• Organization: Jan-Cil Spain

+34 91 7228043

Study Officials

• Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial

  Janssen-Cilag, S.A.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2010
• First Posted: August 13, 2010
• Study Start: May 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: May 1, 2014
• Results First Posted: August 14, 2012

Record last verified: 2014-04

Locations

ES (1)