EUCTR2005-000979-18-CZ
Active, not recruiting
Phase 1
A phase IIa/b double-blind, randomised, placebo-controlled, linear trend design dose-ranging study to investigate the effects of 24 weeks of monotherapy with SB-742457 on cognition in subjects with mild to moderate Alzheimer's disease
GlaxoSmithKline Research & Development Ltd0 sites0 target enrollmentStarted: June 15, 2005Last updated:
ConditionsAlzheimer’s disease
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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\. Fifty to 85 years of age inclusive.
- •4\. 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.
- •5\. Subject has the ability to comply with procedures for cognitive and other testing.
- •6\. 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.)
- •7\. 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.
- •8\. 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:
Exclusion Criteria
- •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
Investigators
Similar Trials
Active, not recruiting
Phase 1
A phase IIa/b double-blind, randomised, placebo-controlled, linear trend design dose-ranging study to investigate the effects of 24 weeks of monotherapy with SB-742457 on cognition in subjects with mild to moderate Alzheimer's diseaseAlzheimer’s diseaseEUCTR2005-000979-18-SKGlaxoSmithKline Research & Development Ltd380
Active, not recruiting
Phase 1
A phase IIa/b double-blind, randomised, placebo-controlled, linear trend design dose-ranging study to investigate the effects of 24 weeks of monotherapy with SB-742457 on cognition in subjects with mild to moderate Alzheimer's diseaseEUCTR2005-000979-18-ATGlaxoSmithKline Research & Development Ltd
Active, not recruiting
Phase 1
A phase IIa/b double-blind, randomised, placebo-controlled, linear trend design dose-ranging study to investigate the effects of 24 weeks of monotherapy with SB-742457 on cognition in subjects with mild to moderate Alzheimer's diseaseEUCTR2005-000979-18-ESGlaxoSmithKline Research & Development Ltd
Recruiting
Phase 2
A clinical study to assess the efficacy of a green-lipped mussel (GLM) extract in people with knee osteoarthritis.Knee OsteoarthritisGastrointestinal SymptomsMusculoskeletal - OsteoarthritisACTRN12613000261718Aroma New Zealand Limited110
Active, not recruiting
Phase 1
A study to evaluate the efficacy of KH176 in patients with a genetically confirmed mitochondrial DNA mutation. Patients to be allocated randomly to placebo or investigational drug in different periods; meaning each patient will receive both placebo as well as the investigational drug. Assignment of actual treatment order will be unknown to patient and doctor.A genetically confirmed mitochondrial desoxyribonucleic acid (DNA) transfer ribonucleic acid (tRNA)Leu(UUR) m.3243A>G mutation (including but not limited to MELAS, MIDD and mixed compositions).Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]EUCTR2019-000599-40-GBKhondrion B.V.27