A double-blind, randomised, placebo-controlled, parallel group study to investigate the effects of SB-742457, donepezil and placebo on cognition in subjects with mild to moderate Alzheimer's Disease
- Conditions
- Alzheimer's disease
- Registration Number
- EUCTR2006-000468-95-GB
- Lead Sponsor
- GlaxoSmithKline Research & Development Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
A subject will be eligible for inclusion in the study only if all of the following criteria apply:
1.Male or female subject with a clinical diagnosis of probable Alzheimer's disease in accordance with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria and National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
2.Subject has mild to moderate Alzheimer's disease with MMSE score 12-24 inclusive at the screening visit and 12-26 inclusive at the end of the placebo run-in period .
3.Subject has a documented history of symptoms of Alzheimer’s disease for at least 6 months prior to entry into the study.
4.Age = 50 to = 85 years.
5.Female subjects must be post-menopausal (i.e. >24 weeks without menstrual period) or surgically sterile. Female subjects who have been post-menopausal for < 2 years must undertake pregnancy testing (ßhCG) at Visit 1, which must be negative.
6.Subject has the ability to comply with procedures for cognitive and other testing.
7.Subject lives with (or has substantial periods of contact with) a permanent caregiver who is willing to attend all visits, oversee the subject's compliance with protocol specified procedures and study medication, and report on subject's status. (Subjects living in a nursing home are not eligible.)
8.Subject has provided full written informed consent prior to the performance of any protocol-specified procedure; or if unable to provide informed consent due to cognitive status, full written informed consent on behalf of the subject has been provided by a legally acceptable representative.
9.Caregiver has provided full written informed consent on his/her own behalf prior to the performance of any protocol-specified procedure.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
Other Causes for Dementia
1.Diagnosis of possible, probable or definite vascular dementia in accordance with National Institute of Neurological Disorders and Stroke-Association Internationale pour la Recherche l’Enseignement en Neurosciences (NINDS-AIREN) criteria.
2.History and/or evidence (CT or MRI scan performed within the past 12 months or at Screening) of any other central nervous system (CNS) disorder that could be interpreted as a cause of dementia: e.g. cerebrovascular disease, structural or developmental abnormality, epilepsy, infectious, degenerative or inflammatory/demyelinating CNS conditions.
3.Focal findings on the neurological exam (excluding changes attributable to peripheral injury).
4.Untreated abnormal result of any of the following tests: vitamin B12, syphilis serology, thyroid stimulating hormone (TSH), where this is thought to be the cause of, or to contribute to the severity of, the subject’s dementia.
Confounding Medical Conditions
5.History of significant psychiatric illness such as schizophrenia or bipolar affective disorder that in the opinion of the Investigator would interfere with participation in the study, or current depression (score on Centre for Epidemiological Studies - Depression Scale (CES-D) >18).
6.History of known or suspected seizures, including febrile seizures, unexplained recent loss of consciousness or history of significant head trauma with loss of consciousness.
7.Known history of photosensitivity or presence of skin conditions (such as porphyria, photo-dermatitis) or treatments (such as medications, UV light) that may predispose the subject to photosensitivity reactions.
8.Any significant medical conditions which, in the opinion of the investigator, may be exacerbated by administration of donepezil (e.g. chronic obstructive pulmonary disease, asthma, peptic ulcer disease).
9.History or presence of significant cardiovascular, gastro-intestinal, endocrine, hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs, or any other clinically relevant abnormality, medical or psychiatric condition, which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.
10.History of alcohol or other substance abuse, according to the DSM-IV criteria.
Concomitant Medications
11.Treatment with any concomitant medications as detailed in the protocol.
Unacceptable Test/Laboratory Values
12.Systolic blood pressure >165 mmHg or diastolic blood pressure >95 mmHg.
13.Postural hypotension (fall in systolic blood pressure of >30mmHg or fall in diastolic blood pressure of >20mmHg on standing compared to sitting).
14.Abnormal liver/kidney function tests (more than 1.5 times normal).
15.Calculated creatinine clearance < 40ml/min (Cockroft-Gault formula) and/or clinically relevant finding on urinalysis, including microscopy (such as: more than 1+ protein or blood, significant abnormality in albumin/creatinine ratio, etc.)
Other
16.Previous parti
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