Alzheimer's Disease Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Ascending-Dose Phase 1b Safety Study of Three Different Doses of an Alpha-7 Nicotinic Acetylcholine Receptor Agonist (EVP-6124) or Placebo in Patients With Mild to Moderate Probable Alzheimer's Disease
Verified date | April 2012 |
Source | FORUM Pharmaceuticals Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study is being conducted to determine the safety, tolerability, and pharmacokinetics (PK) of three different doses of an investigational medication, EVP-6124, in individuals with mild to moderate Alzheimer's disease who are also taking an Alzheimer's medication (AChEI [acetylcholinesterase inhibitor]: either donepezil or rivastigmine). In addition, PK of AChEI medications will be assessed. Cognitive function will be evaluated on an exploratory basis.
Status | Completed |
Enrollment | 49 |
Est. completion date | March 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years to 90 Years |
Eligibility |
Inclusion Criteria: - male and post-menopausal or surgically sterile female pts - 50-90 yrs old, who meet clinical criteria for probable Alzheimer's disease (Mini-Mental State Examination of 18-26; Hachinski Ischemic Score =4) - must be taking donepezil or rivastigmine for at least 3 mos. Exclusion Criteria: - Unstable medical condition that is clinically significant in the judgment of the investigator; major organ system dysfunction - Untreated hypothyroidism - Insufficiently controlled diabetes mellitus - Diagnosis of major depression requiring antidepressant medications within the last 5 years - Stroke within 6 months before screening, or concomitant with onset of dementia - Certain concomitant medications |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Comprehensive Clinical Research | Berlin | New Jersey |
United States | MD Clinical | Hallandale Beach | Florida |
United States | Global Medical Institutes, LLC | Princeton | New Jersey |
United States | Pacific Research Network, Inc. | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
FORUM Pharmaceuticals Inc | INC Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and Tolerability of Multiple Doses of EVP-6124 or Placebo in Subjects With Alzheimer's Disease | All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram), ambulatory ECG, and laboratory tests (hematology/blood chemistry/urinalysis) | Pre-treatment (Day -2) [or screening for physical examination] to Day 28 [or Day 35, for AEs only] | Yes |
Secondary | EVP-6124 PK Data Following the First Dose of EVP-6124 - Maximum Concentration (Cmax) | EVP-6124 PK data; Maximum Concentration (Cmax); i.e, highest concentration of drug in plasma | 24 hours | No |
Secondary | EVP-6124 PK Data Following the First Dose of EVP-6124 - Time to Maximum Concentration (Tmax) | EVP-6124 PK data; Time to Maximum Concentration (Tmax); i.e, amount of time required to reach highest concentration of drug in plasma | 24 hours | No |
Secondary | EVP-6124 PK Data Following the First Dose of EVP-6124 - Area Under the Curve (AUC[0-24 h]) | EVP-6124 PK data; Area Under the Curve (AUC[0-24 h]); i.e, area under the concentration-time plot | 24 hours | No |
Secondary | Donepezil PK Data Following the First Dose of EVP-6124 - Maximum Concentration (Cmax) | Donepezil PK data; Maximum Concentration (Cmax); i.e, highest concentration of donepezil (parent compound only) in plasma after dosing with EVP-6124 | 24 hours | No |
Secondary | Donepezil PK Data Following the First Dose of EVP-6124 - Time to Maximum Concentration (Tmax) | Donepezil PK data; Time to Maximum Concentration (Tmax); i.e, amount of time required to reach highest concentration of donepezil (parent compound only) in plasma after dosing with EVP-6124 | 24 hours | No |
Secondary | Donepezil PK Data Following the First Dose of EVP-6124 - Area Under the Curve (AUC[0-24 h]) | Donepezil PK data; Area Under the Curve (AUC[0-24 h]); i.e, area under the concentration-time plot for donepezil (parent compound only) after dosing with EVP-6124 | 24 hours | No |
Secondary | Rivastigmine PK Data Following the First Dose of EVP-6124 - Maximum Concentration (Cmax) | Rivastigmine PK data; Maximum Concentration (Cmax); i.e, highest concentration of rivastigmine in plasma after dosing with EVP-6124 | 24 hours | No |
Secondary | Rivastigmine PK Data Following the First Dose of EVP-6124 - Time to Maximum Concentration (Tmax) | Rivastigmine PK data; Time to Maximum Concentration (Tmax); i.e, amount of time required to reach highest concentration of rivastigmine in plasma after dosing with EVP-6124 | 24 hours | No |
Secondary | Rivastigmine PK Data Following the First Dose of EVP-6124 - Area Under the Curve (AUC[0-24 h]) | Rivastigmine PK data; Area Under the Curve (AUC[0-24 h]); i.e, area under the concentration-time plot for rivastigmine after dosing with EVP-6124 | 24 hours | No |
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