Phase 3
N=933
Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil
Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01955161 ↗Enrolled (actual)
933
Serious AEs
5.4%
Results posted
Sep 2017
Primary outcome: Primary: Change in Cognition — 0.13; 0.47; 0.18 units on a scale — p=0.9591
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
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cognition |
0.13; 0.47; 0.18 | 0.9591 |
| SECONDARY Change in Daily Functioning |
-2.03; -2.12; -2.02 | 1.000 |
| SECONDARY Change in Global Impression |
4.29; 4.32; 4.13 | 1.000 |
| SECONDARY Change in Behavioural Disturbance |
-0.21; -0.21; -0.39 | — |
| SECONDARY Change in Individual Behavioural Disturbance Items |
-0.11; -0.04; -0.01; 0.13; 0.03; -0.03 | — |
| SECONDARY Change in NPI Anxiety Item Score in Patients With an NPI Anxiety Item Score of at Least 2 at Baseline |
-1.12; -1.56; -1.64 | — |
| SECONDARY Clinical Improvement |
34; 37; 27 | — |
| SECONDARY Clinical Worsening |
40; 42; 33 | — |
| SECONDARY Change in Cognitive Aspects of Mental Function |
0.06; -0.27; 0.27 | — |
| SECONDARY Change in Health-related Quality of Life (EQ-5D) Utility Score |
-0.01; 0.00; 0.00 | — |
| SECONDARY Change in Health-related Quality of Life (EQ-5D VAS) |
-0.40; -0.12; 0.34 | — |
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 (NCT01955161). 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.