A Randomized, Double-blind, Placebo-controlled Trial of Long-term (2-year) Treatment of Galantamine in Mild to Moderately-severe Alzheimer’s Disease
- Conditions
- Mild to moderately severe Alzheimer's DiseaseMedDRA version: 9.1Level: LLTClassification code 10001896Term: Alzheimer's disease
- Registration Number
- EUCTR2007-002780-27-AT
- Lead Sponsor
- Janssen Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2000
FULL CRITERIA IN PROTOCOL
• Outpatients (men or women), 45 to 90 years of age, inclusive
• Women must be postmenopausal (for at least 1 year), surgically sterile, sexually abstinent or if sexually active be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study. Women of childbearing potential must have a negative serum ß-hCG or urine pregnancy test at screening and at times as deemed appropriate by
the investigator.
• Diagnosed with mild to moderately-severe, probable or possible AD established in accordance with the criteria defined by the NINCDS-ADRDA or DSM-IV. Subjects presenting with AD, with or without CVD may be enrolled.
• A computed tomography (CT) or magnetic resonance imaging (MRI) of the head done since the 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, it will have to be performed for inclusion in the study.
• An MMSE score of 10 to 26 inclusive, at screening (Visit 1)
• Be living at home or in residential/nursing homes
• Be living with or have regular and frequent visits from a responsible caregiver. The caregiver must supervise the regular administration of the study medication to the subject to improve compliance and avoid dosage errors, be willing to provide information about the subject, and prepared to accompany the subject for scheduled visit assessments for the full 2-year duration of the study. Note: There may be more than 1 caregiver. However, the same caregiver should assess the subject throughout the study whenever possible. Because of the long-term nature of the study, it is highly desirable that, 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 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 in accordance with the requirements of the ethical review committee
• Informed consent must also be given by the caregiver for their own participation in the study for the full 2-year period
• The subject and caregiver (or their legally acceptable representative) must be able to speak, read, and write in the language of the tests being administered and must be able to complete all testing
• To participate in the optional pharmacogenomic component of this study, subjects (or their legally acceptable representative) must have signed the informed consent form (ICF) for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study (where local regulations permit). Refusal to consent for this component does not exclude a subject from participation in the clinical study.
• Willing to adhere to the prohibitions and restrictions specified in this
protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method