Idalopirdine in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil
- Registration Number
- NCT02006641
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
To establish efficacy of Idalopirdine as adjunctive therapy to donepezil for symptomatic treatment of patients with mild-to-moderate Alzheimer's disease (AD).
- Detailed Description
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 10 mg/day or 30 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 858
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Idalopirdine 30 mg Idalopirdine Idalopirdine adjunct to 10 mg Donepezil Idalopirdine 10 mg Idalopirdine Idalopirdine adjunct to 10 mg Donepezil Placebo Placebo Placebo adjunct to 10 mg Donepezil
- Primary Outcome Measures
Name Time Method Change in Cognition Baseline and Week 24 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).
- Secondary Outcome Measures
Name Time Method Change in Individual Behavioural Disturbance Items Baseline and Week 24 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.Change in NPI Anxiety Item Score in Patients With an NPI Anxiety Item Score of at Least 2 at Baseline Baseline and Week 24 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.Change in Daily Functioning Baseline and Week 24 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).Number of Participants With Clinical Worsening Week 24 Clinical worsening at Week 24 (Based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes \[change in ADAS-cog above or equal to 4, change in ADCS-ADL23 below 0, and ADCS-CGIC above 4\])
Change in Global Impression Baseline and Week 24 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).Change in Behavioural Disturbance Baseline and Week 24 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).Number of Participants With Clinical Improvement Week 24 Clinical response at Week 24 (based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes \[change in ADAS-cog below or equal to -4, change in ADCS-ADL23 at least 0, and ADCS-CGIC below or equal to 4\])
Change in Cognitive Aspects of Mental Function Baseline and Week 24 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).
Change in Health-related Quality of Life (EQ-5D) Utility Score Baseline and Week 24 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.Change in Health-related Quality of Life (EQ-5D VAS) Baseline and Week 24 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).
Trial Locations
- Locations (162)
IL302
🇮🇱Haifa, Israel
US305
🇺🇸Carson, California, United States
US346
🇺🇸Costa Mesa, California, United States
US322
🇺🇸Anaheim, California, United States
US327
🇺🇸Fullerton, California, United States
US307
🇺🇸Redlands, California, United States
US351
🇺🇸Oceanside, California, United States
US315
🇺🇸Lomita, California, United States
US301
🇺🇸Santa Rosa, California, United States
US308
🇺🇸Delray Beach, Florida, United States
US320
🇺🇸Hallandale Beach, Florida, United States
US347
🇺🇸Hialeah, Florida, United States
US340
🇺🇸Lake Worth, Florida, United States
US335
🇺🇸Naples, Florida, United States
US345
🇺🇸Orange City, Florida, United States
US309
🇺🇸Palm Beach Gardens, Florida, United States
US304
🇺🇸Atlanta, Georgia, United States
US302
🇺🇸Sunrise, Florida, United States
US360
🇺🇸Augusta, Georgia, United States
US318
🇺🇸Decatur, Georgia, United States
US350
🇺🇸Belmont, Massachusetts, United States
US310
🇺🇸Saint Paul, Minnesota, United States
US330
🇺🇸Creve Coeur, Missouri, United States
US312
🇺🇸Staten Island, New York, United States
US316
🇺🇸Charlotte, North Carolina, United States
US323
🇺🇸Cincinnati, Ohio, United States
US306
🇺🇸Columbus, Ohio, United States
US333
🇺🇸Oklahoma City, Oklahoma, United States
US352
🇺🇸Lakewood, Ohio, United States
US314
🇺🇸Allentown, Pennsylvania, United States
US324
🇺🇸Pittsburgh, Pennsylvania, United States
US325
🇺🇸Reading, Pennsylvania, United States
US341
🇺🇸Pittsburgh, Pennsylvania, United States
US343
🇺🇸Fort Worth, Texas, United States
AR303
🇦🇷Banfield, Argentina
AR304
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
AR309
🇦🇷Cordoba, Argentina
BR309
🇧🇷Curitiba, Brazil
BR301
🇧🇷Rio de Janeiro, Brazil
BR306
🇧🇷Rio de Janeiro, Brazil
CA302
🇨🇦Kelowna, Canada
CA301
🇨🇦Halifax, Canada
BR308
🇧🇷San Paolo, Brazil
CA306
🇨🇦Montreal, Canada
CA305
🇨🇦Toronto, Canada
CA304
🇨🇦Qubec, Canada
CA303
🇨🇦Sherbrooke, Canada
HR304
🇭🇷Zabok, Croatia
HR302
🇭🇷Zagreb, Croatia
CZ305
🇨🇿Brno, Czechia
CZ310
🇨🇿Praha 10 - Strasnice, Czechia
CZ306
🇨🇿Chocen, Czechia
CZ309
🇨🇿Chocen, Czechia
CZ308
🇨🇿Pardubice, Czechia
CZ304
🇨🇿Praha 10, Czechia
CZ307
🇨🇿Praha 2, Czechia
CZ301
🇨🇿Praha 6, Czechia
CZ303
🇨🇿Praha 6, Czechia
CZ302
🇨🇿Rychnov nad Kneznou, Czechia
EE303
🇪🇪Tallin, Estonia
FR301
🇫🇷Bordeaux, France
FR308
🇫🇷Bron, France
FR304
🇫🇷Dijon, France
FR309
🇫🇷Elancourt, France
FR302
🇫🇷Marseille cedex 5, France
FR307
🇫🇷Colmar cedex, France
FR306
🇫🇷Reims, France
FR303
🇫🇷Nice Cedex 1, France
FR305
🇫🇷Rouen, France
HU305
🇭🇺Budapest, Hungary
HU303
🇭🇺Gyor, Hungary
HU302
🇭🇺Szeged, Hungary
IL303
🇮🇱Holon, Israel
IT306
🇮🇹Brescia, Italy
IT311
🇮🇹Genova, Italy
IL304
🇮🇱Ramat Gan, Israel
IT312
🇮🇹Monza, Italy
IT313
🇮🇹Palermo, Italy
IT307
🇮🇹Perugia, Italy
IT308
🇮🇹Roma, Italy
IT304
🇮🇹Torino, Italy
KR303
🇰🇷Busan, Korea, Republic of
IT305
🇮🇹Roma, Italy
IT310
🇮🇹Torrette, Italy
KR308
🇰🇷Seongnam-si, Korea, Republic of
KR301
🇰🇷Incheon, Korea, Republic of
KR304
🇰🇷Seoul, Korea, Republic of
KR302
🇰🇷Seoul, Korea, Republic of
KR305
🇰🇷Seoul, Korea, Republic of
KR306
🇰🇷Seoul, Korea, Republic of
KR309
🇰🇷Seoul, Korea, Republic of
KR307
🇰🇷Seoul, Korea, Republic of
LT304
🇱🇹Vilnius, Lithuania
PL301
🇵🇱Bialystok, Poland
PL309
🇵🇱Krakow, Poland
PL302
🇵🇱Lodz, Poland
PL303
🇵🇱Poznan, Poland
TW304
🇨🇳Taipei, Taiwan
TW305
🇨🇳Taipei, Taiwan
GB307
🇬🇧Amersham, United Kingdom
GB301
🇬🇧Glasgow, United Kingdom
GB303
🇬🇧London, United Kingdom
GB308
🇬🇧London, United Kingdom
GB306
🇬🇧Plymouth, United Kingdom
GB305
🇬🇧Preston, United Kingdom
GB304
🇬🇧Southampton, United Kingdom
GB309
🇬🇧Warrington, United Kingdom
GB302
🇬🇧Swindon, United Kingdom
US342
🇺🇸Fayetteville, Arkansas, United States
US337
🇺🇸New London, Connecticut, United States
US332
🇺🇸Stamford, Connecticut, United States
US334
🇺🇸Lake Charles, Louisiana, United States
US321
🇺🇸Hattiesburg, Mississippi, United States
US339
🇺🇸Manchester, New Jersey, United States
US319
🇺🇸Port Royal, South Carolina, United States
US356
🇺🇸Cordova, Tennessee, United States
AR301
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
AR308
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
AR311
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
AR313
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
AR314
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
AR315
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
AR312
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
AR307
🇦🇷Córdoba, Argentina
AR305
🇦🇷Godoy Cruz, Argentina
AR310
🇦🇷Mendoza, Argentina
AR302
🇦🇷Santa Fe, Argentina
AR306
🇦🇷Santiago del Estero, Argentina
HR301
🇭🇷Zagreb, Croatia
HR303
🇭🇷Zagreb, Croatia
EE301
🇪🇪Tallinn, Estonia
EE302
🇪🇪Tartu, Estonia
FI302
🇫🇮Kuopio, Finland
FI303
🇫🇮Oulu, Finland
FI301
🇫🇮Turku, Finland
HU304
🇭🇺Budapest, Hungary
HU301
🇭🇺Esztergom, Hungary
IE301
🇮🇪Cork, Ireland
LT302
🇱🇹Kaunas, Lithuania
LT303
🇱🇹Kaunas, Lithuania
LT301
🇱🇹Vilnius, Lithuania
PL304
🇵🇱Bydgoszcz, Poland
PL308
🇵🇱Gdynia, Poland
PL310
🇵🇱Lubin, Poland
PL306
🇵🇱Lublin, Poland
PL307
🇵🇱Oswiecim, Poland
PT301
🇵🇹Amadora, Portugal
PT302
🇵🇹Coimbra, Portugal
TW301
🇨🇳Kaohsiung, Taiwan
TW302
🇨🇳Kaohsiung, Taiwan
TW303
🇨🇳Taichung, Taiwan
IT309
🇮🇹Brescia, Italy
IT302
🇮🇹Naples, Italy
IT301
🇮🇹Pisa, Italy
US338
🇺🇸Phoenix, Arizona, United States
US303
🇺🇸Miami, Florida, United States
US313
🇺🇸Miami, Florida, United States
US344
🇺🇸Boston, Massachusetts, United States
US349
🇺🇸Cleveland, Ohio, United States
US354
🇺🇸Houston, Texas, United States
BR307
🇧🇷Curitiba, Brazil
US336
🇺🇸Winston-Salem, North Carolina, United States