Trial · NCT02079246
Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease
NCT02079246, Phase 3, Completed, H. Lundbeck A/S; results first posted 2018-08-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease. Trials, record NCT02079246. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02079246
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease
- NCT number
- NCT02079246
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,463 participants, actual
- Lead sponsor
- H. Lundbeck A/S
- Conditions
- Alzheimer's Disease
- Interventions
- Idalopirdine 60 mg
- First posted
- 2014-03-05
- Last updated
- 2018-08-10
- Other registries' IDs
- eudract:2013-000001-23
- Results first posted
- 2018-08-10
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Treatment Emergent Adverse Events (TEAEs) in the OLEX | Baseline II (start of OLEX, week 0) to end of OLEX (week 28) | A TEAE is an adverse event that starts or increases in intensity after the date of Baseline II. |
| Primary | Number of TEAEs in the OLEX-MEM | From Baseline III (start of OLEX-MEM, Week 28) to end of OLEX-MEM (Week 52) | A TEAE is an adverse event that starts or increases in intensity after the date of Baseline III (start of OLEX-MEM). |
| Secondary | Change in Cognition | Baseline II (start of OLEX, Week 0) to Week 28 | Change from Baseline II to Week 28 in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) total score. The 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). |
| Secondary | Clinical Global Impression Score | Week 28 | Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score at Week 28. The ADCS-CGIC is a semi-structured interview to assess clinically relevant changes in patients with AD. The items determine cognition, behavior, social and daily functioning. Severity at baseline is rated on a 7-point scale from 1 (normal, not ill at all) to 7 (among the most extremely ill patients). The clinically relevant change from baseline is rated on a 7-point scale from 1 (marked improvement) to 7 (marked worsening). |
| Secondary | Change in Daily Functioning | Baseline II (start of OLEX, Week 0) to Week 28 | Change from Baseline II to Week 28 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL23) total score. The ADCS-ADL23 is a 23-item clinician-rated inventory to assess activities of daily living (conducted with a caregiver or informant). Each item comprises a series of hierarchical sub-questions, ranging from the highest level of independent performance to a complete loss for each activity. Total score of the 23 items ranges from 0 to 78 (higher score indicates lower disability). |
| Secondary | Change in Behavioural Disturbance | Baseline II (start of OLEX, Week 0) to Week 28 | Change from Baseline II to Week 28 in Neuropsychiatric Inventory (NPI) total score. The NPI is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is rated for frequency (a 4-point scale from 1 \[occasionally\] to 4 \[very frequent\]) and severity (a 3-point scale from 1 \[mild\] to 3 \[marked\]). The total NPI score is the frequency ratings multiplied by the severity ratings and ranges from 0 to 144 (higher score indicates worse outcome). |
| Secondary | Change in Cognitive Aspects of Mental Function | Baseline II (start of OLEX, Week 0) to Week 28 | Change from Baseline II to Week 28 in Mini Mental State Examination (MMSE). The MMSE is an 11-item test to assess the cognitive aspects of mental function. The subtests assess orientation, memory, attention, language, and visual construction. The scores for each item is dichotomous (1 = response is correct, 0 = response is incorrect). Total score of the 11 items ranges from 0 to 30 (higher score indicates lower deficit). |
| Secondary | Change in Cognitive Aspects of Mental Function | Baseline III (start of OLEX-MEM, Week 28) to Week 52 | Change from Baseline III to Week 52 in Mini Mental State Examination (MMSE). The MMSE is an 11-item test to assess the cognitive aspects of mental function. The subtests assess orientation, memory, attention, language, and visual construction. The scores for each item is dichotomous (1 = response is correct, 0 = response is incorrect). Total score of the 11 items ranges from 0 to 30 (higher score indicates lower deficit). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Treatment Emergent Adverse Events (TEAEs) in the OLEX | Baseline II (start of OLEX, week 0) to end of OLEX (week 28) | All patients who took at least one dose of IMP in the OLEX. | TEAEs | NUMBER |
| PRIMARY | Number of TEAEs in the OLEX-MEM | From Baseline III (start of OLEX-MEM, Week 28) to end of OLEX-MEM (Week 52) | All patients who took at least one dose of IMP or memantine in the OLEX-MEM. | TEAEs | NUMBER |
| SECONDARY | Change in Cognition | Baseline II (start of OLEX, Week 0) to Week 28 | All patients in who took at least one dose of IMP in the OLEX. | units on a scale | MEAN |
| SECONDARY | Clinical Global Impression Score | Week 28 | All patients in who took at least one dose of IMP in the OLEX. | units on a scale | MEAN |
| SECONDARY | Change in Daily Functioning | Baseline II (start of OLEX, Week 0) to Week 28 | All patients in who took at least one dose of IMP in the OLEX. | units on a scale | MEAN |
| SECONDARY | Change in Behavioural Disturbance | Baseline II (start of OLEX, Week 0) to Week 28 | All patients in who took at least one dose of IMP in the OLEX. | units on a scale | MEAN |
| SECONDARY | Change in Cognitive Aspects of Mental Function | Baseline II (start of OLEX, Week 0) to Week 28 | All patients in who took at least one dose of IMP in the OLEX. | units on a scale | MEAN |
| SECONDARY | Change in Cognitive Aspects of Mental Function | Baseline III (start of OLEX-MEM, Week 28) to Week 52 | All patients who took at least one dose of IMP or memantine in the OLEX-MEM. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Treatment Emergent Adverse Events (TEAEs) in the OLEX | Idalopirdine 60 mg | 2130 | TEAEs | ||
| Number of TEAEs in the OLEX-MEM | Idalopirdine 60 mg + Memantine | 93 | TEAEs | ||
| Change in Cognition | Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14681A | 3.01 | Standard Error 0.22 | units on a scale | |
| Change in Cognition | Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14862A | 2.67 | Standard Error 0.23 | units on a scale | |
| Clinical Global Impression Score | Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14681A | 4.58 | Standard Error 0.005 | units on a scale | |
| Clinical Global Impression Score | Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14862A | 4.61 | Standard Error 0.05 | units on a scale | |
| Change in Daily Functioning | Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14681A | -3.71 | Standard Error 0.28 | units on a scale | |
| Change in Daily Functioning | Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14862A | -3.88 | Standard Error 0.32 | units on a scale | |
| Change in Behavioural Disturbance | Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14681A | 1.80 | Standard Error 0.35 | units on a scale | |
| Change in Behavioural Disturbance | Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14862A | 1.36 | Standard Error 0.34 | units on a scale |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| OLEX | STARTED | Idalopirdine 60 mg | 1,463 | |
| OLEX | STARTED | Idalopirdine 60 mg + Memantine | 0 | |
| OLEX | COMPLETED | Idalopirdine 60 mg | 1,235 | |
| OLEX | COMPLETED | Idalopirdine 60 mg + Memantine | 0 | |
| OLEX | NOT COMPLETED | Idalopirdine 60 mg | 228 | |
| OLEX | NOT COMPLETED | Idalopirdine 60 mg + Memantine | 0 | |
| OLEX-MEM | STARTED | Idalopirdine 60 mg | 0 | |
| OLEX-MEM | STARTED | Idalopirdine 60 mg + Memantine | 101 | |
| OLEX-MEM | COMPLETED | Idalopirdine 60 mg | 0 | |
| OLEX-MEM | COMPLETED | Idalopirdine 60 mg + Memantine | 82 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events232
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Accidental overdose | Injury, poisoning and procedural complications | Idalopirdine 60 mg | 105 | 1,462 | |
| other | Accidental overdose | Injury, poisoning and procedural complications | Idalopirdine 60 mg + Memantine | 6 | 101 | |
| other | Fall | Injury, poisoning and procedural complications | Idalopirdine 60 mg | 80 | 1,462 | |
| other | Fall | Injury, poisoning and procedural complications | Idalopirdine 60 mg + Memantine | 1 | 101 | |
| serious | Acute coronary syndrome | Cardiac disorders | Idalopirdine 60 mg | 1 | 1,462 | |
| serious | Acute coronary syndrome | Cardiac disorders | Idalopirdine 60 mg + Memantine | 0 | 101 | |
| serious | Acute myocardial infarction | Cardiac disorders | Idalopirdine 60 mg | 1 | 1,462 | |
| serious | Acute myocardial infarction | Cardiac disorders | Idalopirdine 60 mg + Memantine | 0 | 101 | |
| serious | Angina pectoris | Cardiac disorders | Idalopirdine 60 mg | 1 | 1,462 | |
| serious | Angina pectoris | Cardiac disorders | Idalopirdine 60 mg + Memantine | 0 | 101 |
1 to 10 of 232Source ClinicalTrials.gov
See all 232 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Idalopirdine 60 mg | 11 | 1,462 |
| Total, all-cause mortality | Idalopirdine 60 mg + Memantine | 0 | 101 |
| Total, other adverse events | Idalopirdine 60 mg | 182 | 1,462 |
| Total, other adverse events | Idalopirdine 60 mg + Memantine | 7 | 101 |
| Total, serious adverse events | Idalopirdine 60 mg | 91 | 1,462 |
| Total, serious adverse events | Idalopirdine 60 mg + Memantine | 2 | 101 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Idalopirdine 60 mg vs Idalopirdine 60 mg + Memantine: deaths from any cause | Trial comparisons |
| Idalopirdine 60 mg vs Idalopirdine 60 mg + Memantine: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02079246
GET https://conductscience.org/api/trials/v1/NCT02079246/events?page=2