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NCT01955161 · ClinicalTrials.gov registry record · Phase 3
Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil
A Phase 3 study of Alzheimers Disease, sponsored by H. Lundbeck A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 933
- Enrollment target
- 20
- Study locations
NCT01955161: Completed Phase 3 study of Alzheimers Disease, sponsored by H. Lundbeck A/S.
NCT01955161 is a Phase 3 study of Alzheimers Disease that has completed, run by H. Lundbeck A/S. The registered enrollment target is 933 participants, below the 3,920-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01955161, a Phase 3 study of Alzheimers Disease, has completed, sponsored by H. Lundbeck A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 933 participants
- Enrollment target
- 20
- Study locations
Study Summary
To establish efficacy of idalopirdine as adjunctive therapy to donepezil for symptomatic treatment of patients with mild-to-moderate Alzheimer's disease (AD).
Primary Outcome
Change from baseline to Week 24 in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) total score. The Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-cog) is a 11-item neuropsychological test that assess the severity of cognitive impairment. The items determine the patient's orientation, memory, language, and praxis. Total score of the 11 items range from 0 to 70 (lower score indicates lower cognitive impairment).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Idalopirdine
Study Locations (20)
California
- US053 - Glendale
- US023 - Imperial
- US015 - La Jolla
- US045 - Long Beach
- US002 - Los Angeles
- US058 - San Francisco
- US018 - Santa Ana
Florida
- US042 - Boca Raton
- US021 - Bradenton
- US050 - Brooksville
- US019 - Orlando
- US038 - Port Charlotte
- US001 - West Palm Beach
Alabama
- US027 - Birmingham
Arizona
- US012 - Phoenix
Arkansas
- US024 - Little Rock
Colorado
- US060 - Denver
Georgia
- US020 - Atlanta
Hawaii
- US048 - Kailua
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 933 participants |
| Start Date | 2013-10 |
| Est. Completion | 2016-07 |
| Phase | Phase 3 |
What the finished NCT01955161 record still lists
NCT01955161 is an interventional study that assigns participants to a tested intervention. The registered 933 participants enrollment target is mid-sized for trials with a published cap, below the 3,920-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Alzheimers Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01955161 names 20 study sites across 9 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT01955161 about?
NCT01955161 is a clinical study titled "Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil". To establish efficacy of idalopirdine as adjunctive therapy to donepezil for symptomatic treatment of patients with mild-to-moderate Alzheimer's disease (AD).
What is the current status of trial NCT01955161?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 933 participants. The study started on 2013-10. Estimated completion is 2016-07.
What conditions does trial NCT01955161 study?
This clinical trial studies the following conditions: Alzheimers Disease.
What interventions are being tested in trial NCT01955161?
The interventions under investigation include: Placebo (DRUG), Idalopirdine (DRUG).
Who is sponsoring clinical trial NCT01955161?
This trial is sponsored by H. Lundbeck A/S, which has 72 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01955161 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alzheimers Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01955161's enrollment target sits among peer trials
933 15th of 147 higher than 133 of 147 other Alzheimers Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimers Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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