Phase 3
N=858
Idalopirdine in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil
Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02006641 ↗Enrolled (actual)
858
Serious AEs
4.7%
Results posted
Feb 2018
Primary outcome: Primary: Change in Cognition — 0.64; 0.55; 1.27 units on a scale — p=1.000
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
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cognition |
0.64; 0.55; 1.27 | 1.000 |
| SECONDARY Change in Daily Functioning |
-1.39; -1.22; -1.36 | 1.000 |
| SECONDARY Change in Global Impression |
4.30; 4.24; 4.35 | 1.000 |
| SECONDARY Change in Behavioural Disturbance |
-0.31; -0.94; -0.54 | — |
| SECONDARY Change in Individual Behavioural Disturbance Items |
0.01; -0.18; 0.00; 0.00; -0.06; -0.03 | — |
| SECONDARY Change in NPI Anxiety Item Score in Patients With an NPI Anxiety Item Score of at Least 2 at Baseline |
-1.48; -1.82; -1.69 | — |
| SECONDARY Number of Participants With Clinical Improvement |
20; 33; 22 | — |
| SECONDARY Number of Participants With Clinical Worsening |
27; 28; 27 | — |
| SECONDARY Change in Cognitive Aspects of Mental Function |
-0.24; -0.45; -0.34 | — |
| SECONDARY Change in Health-related Quality of Life (EQ-5D) Utility Score |
0.03; 0.02; 0.01 | — |
| SECONDARY Change in Health-related Quality of Life (EQ-5D VAS) |
1.35; 1.87; 1.00 | — |
Summary
To establish efficacy of Idalopirdine as adjunctive therapy to donepezil for symptomatic treatment of patients with mild-to-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 donepezil.
- 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 donepezil 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 (NCT02006641). 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.