Phase 1
N=49
Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Alzheimer's Disease
Alzheimer's Disease · Central Nervous System Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00766363 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcome: Primary: Safety and Tolerability of Multiple Doses of EVP-6124 or Placebo in Subjects With Alzheimer's Disease — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- EVP-6124 (0.1 mg/day) (Drug); EVP-6124 (0.3 mg/day) (Drug); EVP-6124 (1.0 mg/day) (Drug); Comparator: Placebo (Drug); Donepezil (Drug); Rivastigmine (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- FORUM Pharmaceuticals Inc
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability of Multiple Doses of EVP-6124 or Placebo in Subjects With Alzheimer's Disease |
0; 0; 0; 0; 2; 3 | — |
| SECONDARY EVP-6124 PK Data Following the First Dose of EVP-6124 - Maximum Concentration (Cmax) |
0.0715; 0.1911; 0.6122 | — |
| SECONDARY EVP-6124 PK Data Following the First Dose of EVP-6124 - Time to Maximum Concentration (Tmax) |
7.70; 7.94; 10.72 | — |
| SECONDARY EVP-6124 PK Data Following the First Dose of EVP-6124 - Area Under the Curve (AUC[0-24 h]) |
1.31; 3.89; 11.44 | — |
| SECONDARY Donepezil PK Data Following the First Dose of EVP-6124 - Maximum Concentration (Cmax) |
29.5; 24.7; 39.2; 41.9 | — |
| SECONDARY Donepezil PK Data Following the First Dose of EVP-6124 - Time to Maximum Concentration (Tmax) |
2.30; 1.85; 3.31; 3.56 | — |
| SECONDARY Donepezil PK Data Following the First Dose of EVP-6124 - Area Under the Curve (AUC[0-24 h]) |
299; 240; 345; 427 | — |
| SECONDARY Rivastigmine PK Data Following the First Dose of EVP-6124 - Maximum Concentration (Cmax) |
23.35; 3.51 | — |
| SECONDARY Rivastigmine PK Data Following the First Dose of EVP-6124 - Time to Maximum Concentration (Tmax) |
1.00; 12.12 | — |
| SECONDARY Rivastigmine PK Data Following the First Dose of EVP-6124 - Area Under the Curve (AUC[0-24 h]) |
143.55; 54.60 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00766363). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.