Phase 3
N=734
Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor
Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02006654 ↗Enrolled (actual)
734
Serious AEs
6.9%
Results posted
Feb 2018
Primary outcome: Primary: Change in Cognition — 0.68; 0.13 units on a scale — p=0.2365
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); Idalopirdine (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- H. Lundbeck A/S
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cognition |
0.68; 0.13 | 0.2365 |
| SECONDARY Change in Global Impression |
4.32; 4.39 | 0.4064 |
| SECONDARY Change in Daily Functioning |
-1.72; -1.05 | 0.4064 |
| SECONDARY Change in Behavioural Disturbance |
-0.46; -0.74 | — |
| SECONDARY Change in Individual Behavioural Disturbance Items |
-0.00; 0.03; 0.05; 0.08; 0.15; 0.03 | — |
| SECONDARY Change in NPI Anxiety Item Score in Patients With an NPI Anxiety Item Score of at Least 2 at Baseline |
-1.93; -1.52 | — |
| SECONDARY Clinical Improvement |
32; 35 | — |
| SECONDARY Clinical Worsening |
37; 40 | — |
| SECONDARY Change in Cognitive Aspects of Mental Function |
-0.64; -0.35 | — |
| SECONDARY Change in Health-related Quality of Life (EQ-5D) Utility Score |
-0.01; -0.00 | — |
| SECONDARY Change in Health-related Quality of Life (EQ-5D VAS) |
-0.40; 0.51 | — |
Summary
To establish efficacy of idalopirdine as adjunctive therapy to acetylcholinesterase inhibitors (AChEIs) for symptomatic treatment of patients with mild-moderate Alzheimer's disease (AD).
Eligibility Criteria
Inclusion Criteria
- The patient has a knowledgeable and reliable caregiver.
- The patient is an outpatient.
- The patient has probable AD.
- The patient has mild to moderate AD.
- Stable treatment with an AChEI.
- The patient, if a woman, must have had her last natural menstruation ≥24 months prior to baseline, OR be surgically sterile.
- The patient, if a man, agrees to protocol-defined use of effective contraception if his female partner is of childbearing potential, OR must have been surgically sterilised prior to the screening visit.
Exclusion Criteria
- The patient has evidence of any clinically significant neurodegenerative disease, or other serious neurological disorders other than AD.
- The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) Axis I disorder other than AD.
- The patient has evidence of clinically significant disease.
- The patient's current AChEI therapy is likely to be interrupted or discontinued during the study.
- The patient is currently receiving memantine or has taken memantine within 2 months prior to screening.
Other inclusion and exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02006654). 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.