A double-blind, placebo-controlled, 2-year study of galantamine used to treat patients with Mild to Moderate Alzheimer's disease.
- Conditions
- Mild to moderately severe Alzheimer's DiseaseMedDRA version: 14.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2007-002780-27-EE
- 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 (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
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