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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004763-45 | EudraCT Number |
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| Name | Class |
|---|---|
| Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
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To establish efficacy of idalopirdine as adjunctive therapy to donepezil for symptomatic treatment of patients with mild-to-moderate Alzheimer's disease (AD).
The study consisted of a screening period (up to 2-week period from screening to randomization), a 24-week double-blind treatment period with placebo or idalopirdine 30 mg/day or 60 mg/day as adjunctive therapy to donepezil 10 mg/day, and a 4-week safety follow-up period following study completion or withdrawal from treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo adjunct to 10 mg Donepezil |
|
| Idalopirdine 30 mg | Experimental | Idalopirdine adjunct to 10 mg Donepezil |
|
| Idalopirdine 60 mg | Experimental | Idalopirdine adjunct to 10 mg Donepezil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Once daily, matching placebo capsules, orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cognition | 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). | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Daily Functioning | Change from baseline to Week 24 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL23) total score. The Alzheimer's Disease Cooperative Study - Activities of Daily Living (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). |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US027 | Birmingham | Alabama | United States | |||
| US012 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31193334 | Derived | Ballard C, Atri A, Boneva N, Cummings JL, Frolich L, Molinuevo JL, Tariot PN, Raket LL. Enrichment factors for clinical trials in mild-to-moderate Alzheimer's disease. Alzheimers Dement (N Y). 2019 May 20;5:164-174. doi: 10.1016/j.trci.2019.04.001. eCollection 2019. | |
| 30474567 | Derived | Cummings JL, Atri A, Ballard C, Boneva N, Frolich L, Molinuevo JL, Raket LL, Tariot PN. Insights into globalization: comparison of patient characteristics and disease progression among geographic regions in a multinational Alzheimer's disease clinical program. Alzheimers Res Ther. 2018 Nov 24;10(1):116. doi: 10.1186/s13195-018-0443-2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo adjunct to 10 mg Donepezil Placebo: Once daily, matching placebo capsules, orally |
| FG001 | Idalopirdine 30 mg | Idalopirdine adjunct to 10 mg Donepezil Idalopirdine: Once daily, encapsulated tablets, orally |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Idalopirdine |
| Drug |
Once daily, encapsulated tablets, orally |
|
| Baseline to Week 24 |
| Change in Global Impression | Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score at Week 24. The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change 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). | Baseline to Week 24 |
| Change in Behavioural Disturbance | Change from baseline to Week 24 in Neuropsychiatric Inventory (NPI) total score. The Neuropsychiatric Inventory 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). | Baseline to Week 24 |
| Change in Individual Behavioural Disturbance Items | Change in single NPI item scores at Week 24. The Neuropsychiatric Inventory 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 then 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]). Total score for each single NPI item ranges from 0-12 (frequency multiplied by severity), where higher scores represent worse outcome. | Baseline to Week 24 |
| Change in NPI Anxiety Item Score in Patients With an NPI Anxiety Item Score of at Least 2 at Baseline | Change from baseline to Week 24 in NPI anxiety item score in patients with an NPI anxiety item score of at least 2 at baseline The Neuropsychiatric Inventory 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 then 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 score for the NPI anxiety item ranges from 0-12 (frequency multiplied by severity), where a higher score represents a worse outcome. | Baseline to Week 24 |
| Clinical Improvement | Clinical response at Week 24 (based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes [change in ADAS-cog below or equal to -4, change in ADCS-ADL23 at least 0, and ADCS-CGIC below or equal to 4]) | Week 24 |
| Clinical Worsening | Clinical worsening at Week 24 (Based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes [change in ADAS-cog above or equal to 4, change in ADCS-ADL23 below 0, and ADCS-CGIC above 4]) | Week 24 |
| Change in Cognitive Aspects of Mental Function | Change from baseline to Week 24 in Mini Mental State Examination (MMSE). The Mini Mental State Examination (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). | Baseline to Week 24 |
| Change in Health-related Quality of Life (EQ-5D) Utility Score | Change from baseline to Week 24 in EuroQol 5-dimensional (EQ-5D) utility score The EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). Each descriptive item is rated on a 3-point index ranging from 1 (no problems) to 3 (extreme problems) that is used for calculating a single summary index (from 0 to 1). A higher EQ-5D score indicates a worse outcome. | Baseline to Week 24 |
| Change in Health-related Quality of Life (EQ-5D VAS) | Change from baseline to Week 24 in EQ-5D Visual Analogue Scale (EQ-5D VAS). The EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). | Baseline to Week 24 |
| Phoenix |
| Arizona |
| United States |
| US024 | Little Rock | Arkansas | United States |
| US053 | Glendale | California | United States |
| US023 | Imperial | California | United States |
| US015 | La Jolla | California | United States |
| US045 | Long Beach | California | United States |
| US002 | Los Angeles | California | United States |
| US058 | San Francisco | California | United States |
| US018 | Santa Ana | California | United States |
| US060 | Denver | Colorado | United States |
| US042 | Boca Raton | Florida | United States |
| US021 | Bradenton | Florida | United States |
| US050 | Brooksville | Florida | United States |
| US019 | Orlando | Florida | United States |
| US038 | Port Charlotte | Florida | United States |
| US001 | West Palm Beach | Florida | United States |
| US020 | Atlanta | Georgia | United States |
| US048 | Kailua | Hawaii | United States |
| US030 | Chicago | Illinois | United States |
| US051 | Joliet | Illinois | United States |
| US040 | Indianapolis | Indiana | United States |
| US036 | Freeport | Maine | United States |
| US032 | Newton | Massachusetts | United States |
| US035 | Kalamazoo | Michigan | United States |
| US041 | Flowood | Mississippi | United States |
| US054 | St Louis | Missouri | United States |
| US046 | Princeton | New Jersey | United States |
| US028 | Toms River | New Jersey | United States |
| US044 | Toms River | New Jersey | United States |
| US049 | Albany | New York | United States |
| US010 | Amherst | New York | United States |
| US014 | Manhasset | New York | United States |
| US008 | New York | New York | United States |
| US029 | New York | New York | United States |
| US056 | New York | New York | United States |
| US037 | Orangeburg | New York | United States |
| US043 | Staten Island | New York | United States |
| US007 | Centerville | Ohio | United States |
| US006 | Columbus | Ohio | United States |
| US052 | Edmond | Oklahoma | United States |
| US026 | Portland | Oregon | United States |
| US057 | Jenkintown | Pennsylvania | United States |
| US047 | Arlington | Virginia | United States |
| US025 | Madison | Wisconsin | United States |
| US004 | Milwaukee | Wisconsin | United States |
| AR002 | Buenos Aires | Argentina |
| AR003 | Buenos Aires | Argentina |
| AR006 | Buenos Aires | Argentina |
| AR007 | Buenos Aires | Argentina |
| AR009 | Córdoba | Argentina |
| AR004 | Mar del Plata | Argentina |
| AR005 | Mendoza | Argentina |
| AR008 | Mendoza | Argentina |
| AR010 | Rosario | Argentina |
| BE003 | Bruges | Belgium |
| BE002 | Brussels | Belgium |
| BE004 | Brussels | Belgium |
| BE005 | Leuven | Belgium |
| BE001 | Roeselare | Belgium |
| BE006 | Thuin | Belgium |
| BG005 | Plovdiv | Bulgaria |
| BG001 | Sofia | Bulgaria |
| BG002 | Sofia | Bulgaria |
| BG003 | Sofia | Bulgaria |
| BG004 | Sofia | Bulgaria |
| BG006 | Sofia | Bulgaria |
| BG007 | Varna | Bulgaria |
| CA002 | Gatineau | Canada |
| CA006 | London | Canada |
| CA008 | Newmarket | Canada |
| CA001 | Toronto | Canada |
| CA004 | Toronto | Canada |
| CL004 | Antofagasta | Chile |
| CL002 | Santiago | Chile |
| CL003 | Santiago | Chile |
| CL005 | Santiago | Chile |
| CL001 | Valdivia | Chile |
| CZ006 | Brno | Czechia |
| CZ007 | Kutná Hora | Czechia |
| CZ004 | Pardubice | Czechia |
| CZ001 | Prague | Czechia |
| CZ002 | Prague | Czechia |
| CZ003 | Prague | Czechia |
| CZ005 | Rychnov nad Kněžnou | Czechia |
| DK003 | Aarhus N | Denmark |
| DK001 | Copenhagen | Denmark |
| DK002 | Odense C | Denmark |
| FR006 | Besançon | France |
| FR008 | Limoges Cedex1 | France |
| FR003 | Nantes | France |
| FR001 | Paris | France |
| FR005 | Paris | France |
| FR004 | Saint-Etienne | France |
| FR002 | Toulouse | France |
| DE002 | Berlin | Germany |
| DE006 | Ellwangen | Germany |
| DE010 | Günzburg | Germany |
| DE005 | Hanover | Germany |
| DE007 | Heidelberg | Germany |
| DE009 | München | Germany |
| DE008 | Ulm | Germany |
| DE004 | Unterhaching | Germany |
| IT004 | Ancona | Italy |
| IT006 | Brescia | Italy |
| IT002 | Florence | Italy |
| IT005 | Genoa | Italy |
| IT003 | Lamezia Terme | Italy |
| IT001 | Milan | Italy |
| IT007 | Palermo | Italy |
| PL004 | Gliwice | Poland |
| PL007 | Katowice | Poland |
| PL005 | Poznan | Poland |
| PL006 | Sopot | Poland |
| PL002 | Szczecin | Poland |
| PL003 | Warsaw | Poland |
| PL008 | Wroclaw | Poland |
| RO002 | Bucharest | Romania |
| RO001 | Târgu Mureş | Romania |
| ZA003 | Bloemfontein | South Africa |
| ZA006 | Cape Town | South Africa |
| ZA007 | Cape Town | South Africa |
| ZA004 | George | South Africa |
| ZA005 | Port Elizabeth | South Africa |
| ZA001 | Pretoria | South Africa |
| ZA002 | Rosebank | South Africa |
| ES002 | Alicante | Spain |
| ES006 | Barcelona | Spain |
| ES001 | Donostia / San Sebastian | Spain |
| ES005 | Manresa | Spain |
| ES004 | Salamanca | Spain |
| ES003 | Santiago de Compostela | Spain |
| UA008 | Dnipropetrovsk | Ukraine |
| UA006 | Kherson,Vil. Stepanivka | Ukraine |
| UA005 | Kyiv | Ukraine |
| UA007 | Kyiv | Ukraine |
| UA001 | Lviv | Ukraine |
| 29318278 | Derived | Atri A, Frolich L, Ballard C, Tariot PN, Molinuevo JL, Boneva N, Windfeld K, Raket LL, Cummings JL. Effect of Idalopirdine as Adjunct to Cholinesterase Inhibitors on Change in Cognition in Patients With Alzheimer Disease: Three Randomized Clinical Trials. JAMA. 2018 Jan 9;319(2):130-142. doi: 10.1001/jama.2017.20373. |
| FG002 | Idalopirdine 60 mg | Idalopirdine adjunct to 10 mg Donepezil Idalopirdine: Once daily, encapsulated tablets, orally |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
A total of 933 patients were randomized into the study but 3 patients were not treated (did not receive IMP). The baseline analysis population only consist of patients who have been treated.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo adjunct to 10 mg Donepezil Placebo: Once daily, matching placebo capsules, orally |
| BG001 | Idalopirdine 30 mg | Idalopirdine adjunct to 10 mg Donepezil Idalopirdine: Once daily, encapsulated tablets, orally |
| BG002 | Idalopirdine 60 mg | Idalopirdine adjunct to 10 mg Donepezil Idalopirdine: Once daily, encapsulated tablets, orally |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| MMSE total score at screening | The Mini Mental State Examination (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). | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Cognition | 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). | All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 24 |
|
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| Secondary | Change in Daily Functioning | Change from baseline to Week 24 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL23) total score. The Alzheimer's Disease Cooperative Study - Activities of Daily Living (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). | All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 24 |
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| Secondary | Change in Global Impression | Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score at Week 24. The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change 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). | All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 24 |
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| Secondary | Change in Behavioural Disturbance | Change from baseline to Week 24 in Neuropsychiatric Inventory (NPI) total score. The Neuropsychiatric Inventory 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). | All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 24 |
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| Secondary | Change in Individual Behavioural Disturbance Items | Change in single NPI item scores at Week 24. The Neuropsychiatric Inventory 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 then 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]). Total score for each single NPI item ranges from 0-12 (frequency multiplied by severity), where higher scores represent worse outcome. | All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure/item assessed | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 24 |
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| Secondary | Change in NPI Anxiety Item Score in Patients With an NPI Anxiety Item Score of at Least 2 at Baseline | Change from baseline to Week 24 in NPI anxiety item score in patients with an NPI anxiety item score of at least 2 at baseline The Neuropsychiatric Inventory 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 then 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 score for the NPI anxiety item ranges from 0-12 (frequency multiplied by severity), where a higher score represents a worse outcome. | All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome/item measure assessed | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 24 |
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| Secondary | Clinical Improvement | Clinical response at Week 24 (based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes [change in ADAS-cog below or equal to -4, change in ADCS-ADL23 at least 0, and ADCS-CGIC below or equal to 4]) | All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed. | Posted | Count of Participants | Participants | No | Week 24 |
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| Secondary | Clinical Worsening | Clinical worsening at Week 24 (Based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes [change in ADAS-cog above or equal to 4, change in ADCS-ADL23 below 0, and ADCS-CGIC above 4]) | All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed. | Posted | Count of Participants | Participants | No | Week 24 |
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| Secondary | Change in Cognitive Aspects of Mental Function | Change from baseline to Week 24 in Mini Mental State Examination (MMSE). The Mini Mental State Examination (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). | All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 24 |
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| Secondary | Change in Health-related Quality of Life (EQ-5D) Utility Score | Change from baseline to Week 24 in EuroQol 5-dimensional (EQ-5D) utility score The EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). Each descriptive item is rated on a 3-point index ranging from 1 (no problems) to 3 (extreme problems) that is used for calculating a single summary index (from 0 to 1). A higher EQ-5D score indicates a worse outcome. | All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Health-related Quality of Life (EQ-5D VAS) | Change from baseline to Week 24 in EQ-5D Visual Analogue Scale (EQ-5D VAS). The EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). | All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 24 |
|
Baseline to end of study at Week 24
Treatment-Emergent Adverse Events are reported in this section
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo adjunct to 10 mg Donepezil | 1 | 308 | 12 | 308 | 39 | 308 |
| EG001 | Idalopirdine 30 mg | Idalopirdine adjunct to 10 mg Donezepil | 1 | 313 | 18 | 313 | 56 | 313 |
| EG002 | Idalopirdine 60 mg | Idalopirdine adjunct to 10 mg Donezepil | 3 | 309 | 20 | 309 | 49 | 309 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Bacterial diarrhoea | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Metastases to peritoneum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Cerebral arteriosclerosis | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cerebral haematoma | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dementia alzheimer's type | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Impulse-control disorder | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vaginal fistula | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Colostomy closure | Surgical and medical procedures | MedDRA 19.0 | Systematic Assessment |
| |
| Rehabilitation therapy | Surgical and medical procedures | MedDRA 19.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Email contact via | H. Lundbeck A/S | +4536301311 | LundbeckClinicalTrials@lundbeck.com |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C568612 | (2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Romania |
|
| Czech Republic |
|
| United States |
|
| Ukraine |
|
| Spain |
|
| Canada |
|
| Belgium |
|
| Denmark |
|
| Poland |
|
| Italy |
|
| South Africa |
|
| Bulgaria |
|
| Chile |
|
| France |
|
| Germany |
|
A negative mean difference indicates a treatment effect in favour of idalopirdine |
| Superiority |
| For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%. | Mixed Models Analysis | Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions | 1.000 | Corrected for multiplicity according to the multiple testing procedure | Mean Difference (Final Values) | 0.05 | Standard Error of the Mean | 0.47 | 2-Sided | 95 | -0.88 | 0.98 | A negative mean difference indicates a treatment effect in favour of idalopirdine. | Superiority |
| Idalopirdine 60 mg |
Idalopirdine adjunct to 10 mg Donepezil Idalopirdine: Once daily, encapsulated tablets, orally |
|
|
|
| Idalopirdine 60 mg |
Idalopirdine adjunct to 10 mg Donepezil Idalopirdine: Once daily, encapsulated tablets, orally |
|
|
|
| OG002 | Idalopirdine 60 mg | Idalopirdine adjunct to 10 mg Donepezil Idalopirdine: Once daily, encapsulated tablets, orally |
|
|
| OG002 |
| Idalopirdine 60 mg |
Idalopirdine adjunct to 10 mg Donepezil Idalopirdine: Once daily, encapsulated tablets, orally |
|
|
| OG002 | Idalopirdine 60 mg | Idalopirdine adjunct to 10 mg Donepezil Idalopirdine: Once daily, encapsulated tablets, orally |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
Idalopirdine adjunct to 10 mg Donepezil
Idalopirdine: Once daily, encapsulated tablets, orally
|
|
| Idalopirdine 60 mg |
Idalopirdine adjunct to 10 mg Donepezil Idalopirdine: Once daily, encapsulated tablets, orally |
|
|
|
|