Alzheimer's Disease MedDRA version: 9.1 Level: LLT Classification code 10001896 Term: Alzheimer's disease
Conditions
Interventions
Product Code: PRX-03140
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Trade Name: Aricept
Pharmaceutical Form: Capsule*
P
Sponsors
EPIX Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Men or women with a clinical diagnosis of probable AD in accordance with NINCDS-ADRDA criteria • MMSE score 16 to 24 inclusive at Screening and Visit 2 • Age =50 and =90 years • Brain CT or MRI scan consistent with a primary diagnosis of AD within 12 months prior to Visit 2 • Neurological examination without focal deficits (excluding changes attributable to peripheral nervous system disease, trauma or congenital birth deficits) • No history or evidence of any other CNS disorder that could likely be interpreted as a cause of dementia: e.g. cerebrovascular disease (stroke, hemorrhage), structural abnormality, epilepsy, infectious or inflammatory/demyelinating CNS conditions, Parkinson’s disease • No diagnosis of possible, probable or definite vascular dementia in accordance with NINDS-AIREN criteria • No history of significant psychiatric illness such as schizophrenia or bipolar affective disorder that, in the opinion of the Investigator, would interfere with study participation. Subjects with major depressive disorder (according to DSM-IV-TR) successfully treated with a stable dose of an antidepressant for at least 6 months prior to Screening may be considered for the study •No evidence of the following: current vitamin B12 deficiency, positive syphilis serology, positive HIV test, or clinical thyroid disease associated with abnormal thyroid function stimulating hormone (TSH) levels. Randomization may be offered to subjects with adequately treated thyroid disease or mild abnormalities in TSH levels without clinical consequence • Cognitive tasks prescribed for cognitive rehabilitation and performed under medical supervision are prohibited for 6 months prior to Visit 2, as well as for the duration of the study• Ability to comply with procedures for cognitive and other testing, and to attend all scheduled study visits • Subject lives with, or has substantial periods of contact with, a regular caregiver who is willing to attend all visits, oversee compliance, and report on subject’s status (Note: a non-cohabitating caregiver must spend sufficient time with the subject so that in the opinion of the Investigator, the caregiver can reliably assess cognitive function, ADLs, and report on the subject’s compliance and health. As guidance, the ability for a caregiver to meet the expected responsibilities for this study would normally require spending at least 7 hours per week with the subject.) • Signed informed consent by the subject (and legal guardian, if applicable) 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
Exclusion criteria
Exclusion criteria: • Any co-morbidity or condition that, in the opinion of the Investigator, may interfere with the assessments and procedures of this protocol • Current or recent history (i.e., within 5 years prior to Screening) of drug (with the exception of nicotine) or alcohol abuse or dependence as defined by DSM-IV-TR criteria for substance-related disorders • Clinically significant laboratory abnormalities, including: o Positive Hepatitis B or C serology o ALT and/or AST, values >2.5 times the upper limit of normal (ULN) o Total bilirubin >1.2 x ULN (unless documented evidence of Gilbert’s syndrome). o Serum creatinine =2.0mg/dL (or calculated creatinine clearance 1 month • If subjects received an AchEI 480 msec in men or >500 msec in women) in individuals not on pacemakers • History of myocardial infarction or coronary artery bypass graft within 3 months of Screening, uncontrolled symptomatic atrial fibrillation or symptomatic ventricular arrhythmias • History of uncontrolled seizure disorder within 12 months of Visit 2 • Use of St. John’s wort, kava kava, ephedra, ginkgo biloba, or other psychoactive herbal medications within 2 weeks prior to Screening • Use of the following prohibited medications: any MAO inhibitors, bupropion, fluoxetine, paroxetine, quinidine • Prior receipt of PRX-03140 • Planned surgery during the study period necessitating general anesthesia • History or presence of gastrointestinal, hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs • Any malignancy within 3 years of Visit 2 (exception: basal or localized squamous cell carcinoma of the skin or cervical cancer in situ, or well circumscribed carcinoma that has been completely surgically excised) • Pregnancy or lactation. Women of childbearing potential and sexually active non-vasectomized men must agree to use a barrier method of contraception during the entire study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of PRX-03140 as compared to placebo on cognitive function as measured by the change from Baseline in ADAS-Cog/13 score in subjects with Alzheimer's Disease;Secondary Objective: • To investigate the effects of PRX-03140 on clinician and caregiver-based impressions of change (CIBIC+) • To investigate the effects of PRX-03140 on measures of behavior and Activities of Daily Living (ADL) • To investigate the effects of PRX-03140 on semantic and working memory, verbal fluency, processing speed, executive function, attention and concentration, using the Neuropsychological Test Battery (NTB) • To assess the safety and tolerability of PRX-03140 • To compare the efficacy and safety of PRX-03140 to donepezil • To compare the efficacy and safety of donepezil to placebo;Primary end point(s): ADAS-Cognitive Score (ADAS-Cog/13) | — |
Countries
United Kingdom
Outcome results
None listed