Mild to moderately severe Alzheimer's Disease MedDRA version: 13.1 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: REMINYL 8mg prolonged-release capsules, hard
(REMINYL 1x täglich 8mg Hartkapseln, retardiert)
Product Name: Galantamine HBr
Product Code: R113675
Pharmaceutical Form: Capsule, hard
INN or
Sponsors
Janssen Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: FULL CRITERIA IN PROTOCOL - Outpatients (M/F) 45 - 90 years of age, inclusive - Women must be postmenopausal (for at least 1 year ), surgically sterile, sexually abstinent or practicing an effective method of birth control - Diagnosed with mild to moderately-severe, probable or possible AD in accordance with criteria defined by the NINCDS ADRDA or DSM-IV. Subjects presenting with AD, with or without CVD may be enrolled. - A computed tomography or MRI of the head done since onset of symptoms leading to the diagnosis of AD. If a CT scan or MRI has not been performed from the time the cognitive symptoms appeared until the subject is screened for this study, an MRI will have to be performed for inclusion in the study. - MMSE score of 10 to 26 inclusive, at screening - Be living at home or in residential/nursing home -Be living with or have regular visits from a caregiver, who will accompany the subject for scheduled visit assessments for duration of the study. The caregiver must supervise the regular administration of the study medication to the subject to improve compliance and avoid dosage errors. - Provide contact information for 2 additional family members or friends willing to provide information about the subject. Apart from that of the caregiver, contact information be available for 1 or preferably 2 additional family members or friends, who are able and willing to provide information about the subject. - Subjects (or legal representatives) and caregiver must sign an informed consent document - The patient and caregiver (or legal representative) must be able to speak, read, and write in the language of the tests and complete all testing - Willing to adhere to the prohibitions & restrictions specified in study protocol - To participate in the optional pharmacogenomic component of this study, subjects (or legally acceptable representative) must have signed the ICF for research indicating willingness to participate in this component of the study (where local regulations permit). Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1600
Exclusion criteria
Exclusion criteria: FULL CRITERIA IN PROTOCOL Neurodegenerative disorders other than AD such as Parkinson's disease, Frontotemperal Dementia or Huntington's Disease. Conditions which may contribute to dementia. Subjects with the co-existing medical conditions such as ongoing diagnosis of untreated epilepsy, major depression, schizophrenia, or other current clinically significant psychiatric disease, severe or uncontrolled behavioral disturbances. Clinically significant cardiovascular disease. Received cholinergic agents for the treatment of dementia within 2 weeks prior to screening. History of drug or alcohol abuse within the last year. History of severe drug allergy or hypersensitivity; including recorded hypersensitivity to cholinesterase inhibitors and its excipients, cholinergic agonists or similar agents, or bromide. Have received an investigational drug or used an experimental medical device within the last 30 days before the planned start of treatment. Subjects who, in the opinion of the investigator, are otherwise unsuitable for a study of this type. Subjects will not be entered in any other clinical study while participating in this study unless approval of the sponsor has been given. Employees of the investigator/study center, with direct involvement in the proposed study/other studies under the direction of that investigator/study center, and family members of the employees or investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The cognitive change from baseline in MMSE score for patients treated with galantamine compared with those treated with matching placebo.;Timepoint(s) of evaluation of this end point: At Month 24;Main Objective: Overall objective The overall objective of this study is to evaluate the benefit-risk of long-term (over the course of 2 years) treatment with galantamine as compared with placebo in subjects with mild to moderately-severe AD. Primary efficacy objective • Compare galantamine with placebo in cognitive change from baseline to Month 24 as measured by the MMSE score Primary safety objective Compare the rate of mortality between subjects randomly assigned to receive galantamine or matching placebo over the course of 2 years. ;Secondary Objective: Secondary efficacy objectives • Compare galantamine with placebo in cognitive change from baseline at Month 6 as measured by the MMSE score • Compare galantamine with placebo in change from baseline over the course of 2 years in activities of daily living as measured by the Disability Assessment in Dementia (DAD) • Compare galantamine with placebo with respect to health care utilization over the course of 2 years as measured by the time to change in the level of accommodation using APAS-CarB • Compare galantamine with placebo over the course of 2 years as measured by a retrospective estimate of caregiver time spent with the subject over the previous 3 months using the APAS-CarB Secondary safety objective Compare the incidence of treatment emergent adverse events, including serious adverse events, between subjects randomly assigned to receive galantamine or matching placebo over the course of 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): i: The cognitive change from baseline in the MMSE score ii: The cognitive change from baseline in DAD scores iii: The time to change in patient accommodation measured using the APAS-CarB ;Timepoint(s) of evaluation of this end point: i: At Month 6 ii: At Month 24 iiI: At protocol-specified time points during the 2 year study (ie, up to 24 months) | — |
Countries
Austria, Czech Republic, Estonia, European Union, France, Germany, Greece, Italy, Latvia, Lithuania, Russian Federation, Slovenia, Ukraine
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed