Phase 2
N=41
A Phase II Study of CPC-201 to Treat Alzheimer's Disease Type Dementia
Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02185053 ↗Enrolled (actual)
41
Serious AEs
19.5%
Results posted
Jun 2020
Primary outcome: Primary: Donepezil Maximum Tolerated Dose (MTD) — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CPC-201 (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Chase Pharmaceuticals Corporation, an affiliate of Allergan plc
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Donepezil Maximum Tolerated Dose (MTD) |
0; 0; 0; 0; 2; 2 | — |
| SECONDARY Number of Subjects With Any TEAEs |
8; 34; 1 | — |
| SECONDARY Donepezil Plasma Concentration at Maximum Tolerated (MTD) or Maximum Allowable Dose |
42.7; 184.2; 188.1; 57.2; 257.5; 269.2 | — |
Summary
This is a Phase II, Single-Blind, Placebo-Controlled, Sequential Treatment, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of CPC-201 in Patients with Alzheimer's Disease Type Dementia.
Eligibility Criteria
Inclusion Criteria
- Aged 50 - 79 years inclusive.
- Meeting the diagnosis of probable Alzheimer's Disease
- Of moderate severity (Mini-Mental Status Exam [MMSE] score 10 - 20 inclusive).
- Patients must be in generally good health as indicated by their medical history and physical examination, vital signs, electrocardiogram (ECG), and standard laboratory tests.
Exclusion Criteria
- Women of child bearing potential.
- History or presence of a seizure disorder.
- History of peptic ulcer disease, urinary or gastric retention; asthma or obstructive pulmonary disease.
- History or presence of bladder outflow obstruction, gastrointestinal obstructive disorder or reduced GI motility, or narrow-angle glaucoma.
- History or presence of gastrointestinal, hepatic, or renal disease, or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- History or presence of myasthenia.
- Known hypersensitivity to donepezil, solifenacin or related drugs.
- Any other clinically relevant acute or chronic diseases which could interfere with patients' safety during the trial, or expose them to undue risk, or which could interfere with study objectives.
- Patients who have participated in another clinical trial with an investigational drug within previous 30 days.
Data sourced from ClinicalTrials.gov (NCT02185053). 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.