Alzheimer's Disease Clinical Trial
— STAR ExtensionOfficial title:
An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease
Verified date | August 2018 |
Source | H. Lundbeck A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the long-term safety and tolerability of idalopirdine (Lu AE58054) as adjunctive therapy to donepezil in patients with mild-moderate Alzheimer's Disease (AD).
Status | Completed |
Enrollment | 1463 |
Est. completion date | July 6, 2017 |
Est. primary completion date | July 6, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - the patient has completed Visit 7 (Completion Visit) in the lead-in double-blind, placebo controlled clinical studies 14861A/NCT01955161 or 14862A/NCT02006641 For patients in the OLEX-MEM: - The patient has completed Visit 6 (Week 28) of the OLEX. - The patient, according to the judgement of the investigator, requires initiation of treatment with memantine as per local label/SmPC/treatment guidelines. Exclusion Criteria: - The patient has a moderate or severe ongoing adverse event from the lead-in study considered a potential safety risk by the investigator. - The patient has experienced seizures before Completion Visit in the lead-in study. - The patient has evidence of clinically significant disease. - The patient's donepezil treatment is likely to be interrupted or discontinued during the study. - The patient is receiving therapy with another acetylcholinesterase inhibitors (AChEI). Other protocol-defined inclusion and exclusion criteria may apply. |
Country | Name | City | State |
---|---|---|---|
Argentina | AR303 | Banfield | |
Argentina | AR007 | Buenos Aires | |
Argentina | AR003 | Ciudad Autonoma Buenos Aires | |
Argentina | AR304 | 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 | AR312 | Ciudad Autonoma de Buenos Aires | |
Argentina | AR009 | Cordoba | |
Argentina | AR307 | Cordoba | |
Argentina | AR309 | Cordoba | |
Argentina | AR305 | Godoy Cruz | |
Argentina | AR004 | Mar del Plata | |
Argentina | AR005 | Mendoza | |
Argentina | AR008 | Mendoza | |
Argentina | AR310 | Mendoza | |
Argentina | AR010 | Rosario | |
Argentina | AR302 | Santa Fe | |
Argentina | AR306 | Santiago del Estero | |
Belgium | BE003 | Brugge | |
Belgium | BE002 | Brussels | |
Belgium | BE004 | Bruxelles | |
Belgium | BE005 | Leuven | |
Belgium | BE001 | Roeselare | |
Brazil | BR307 | Curitiba | |
Brazil | BR309 | Curitiba | |
Brazil | BR303 | Porto Alegre | |
Brazil | BR301 | Rio de Janeiro | |
Brazil | BR306 | Rio de Janeiro | |
Brazil | BR302 | Sao Paulo | |
Brazil | BR304 | São Paulo | |
Brazil | BR308 | São Paulo | |
Bulgaria | BG005 | Plovdiv | |
Bulgaria | BG001 | Sofia | |
Bulgaria | BG002 | Sofia | |
Bulgaria | BG003 | Sofia | |
Bulgaria | BG004 | Sofia | |
Bulgaria | BG006 | Sofia | |
Canada | CA002 | Gatineau | |
Canada | CA309 | Gatineau | |
Canada | CA301 | Halifax | |
Canada | CA302 | Kelowna | |
Canada | CA006 | London | |
Canada | CA306 | Montreal | |
Canada | CA008 | Newmarket | |
Canada | CA304 | Qubec | |
Canada | CA001 | Toronto | |
Canada | CA305 | Toronto | |
Canada | CA308 | Toronto | |
Canada | CA307 | Verdun | |
Chile | CL004 | Antofagasta | |
Chile | CL002 | Santiago | |
Chile | CL003 | Santiago | |
Chile | CL005 | Santiago | |
Chile | CL001 | Valdivia | |
Croatia | HR304 | Zabok | |
Croatia | HR301 | Zagreb | |
Croatia | HR302 | Zagreb | |
Czechia | CZ006 | Brno | |
Czechia | CZ309 | Chocen | |
Czechia | CZ306 | Hradec Kralove | |
Czechia | CZ007 | Kutna Hora | |
Czechia | CZ004 | Pardubice | |
Czechia | CZ003 | Praha 10 | |
Czechia | CZ304 | Praha 10 | |
Czechia | CZ310 | Praha 10 - Strasnice | |
Czechia | CZ001 | Praha 2 | |
Czechia | CZ002 | Praha 6 | |
Czechia | CZ301 | Praha 6 | |
Czechia | CZ303 | Praha 6 | |
Czechia | CZ005 | Rychnov nad Kneznou | |
Denmark | DK003 | Aarhus N | |
Denmark | DK001 | Copenhagen | |
Estonia | EE303 | Tallin | |
Estonia | EE301 | Tallinn | |
Estonia | EE302 | Tartu | |
Finland | FI302 | Kuopio | |
Finland | FI303 | Oulu | |
Finland | FI301 | Turku | |
France | FR006 | Besancon Cedex | |
France | FR301 | Bordeaux | |
France | FR308 | Bron cedex | |
France | FR309 | Elancourt | |
France | FR008 | Limoges | |
France | FR302 | Marseille cedex 5 | |
France | FR312 | Nantes | |
France | FR003 | Nantes Cedex | |
France | FR303 | Nice | |
France | FR001 | Paris | |
France | FR311 | Paris | |
France | FR005 | Paris cedex 10 | |
France | FR306 | Reims | |
France | FR305 | Rouen | |
France | FR004 | Saint Priest en Jarez | |
France | FR313 | Saint Priest en Jarez | |
France | FR002 | Toulouse | |
Germany | DE002 | Berlin | |
Germany | DE006 | Ellwangen | |
Germany | DE005 | Hannover | |
Germany | DE007 | Heidelberg | |
Germany | DE009 | Munchen | |
Germany | DE008 | Ulm | |
Germany | DE004 | Unterhaching | |
Hungary | HU304 | Budapest | |
Hungary | HU305 | Budapest | |
Hungary | HU301 | Esztergom | |
Hungary | HU302 | Szeged | |
Israel | IL302 | Haifa | |
Israel | IL303 | Holon | |
Israel | IL304 | Ramat Gan | |
Italy | IT004 | Ancona | |
Italy | IT006 | Brescia | |
Italy | IT306 | Brescia | |
Italy | IT309 | Brescia | |
Italy | IT313 | Cefalù | |
Italy | IT002 | Firenze | |
Italy | IT311 | Genova | |
Italy | IT003 | Lamezia Terme | |
Italy | IT001 | Milano | |
Italy | IT312 | Monza | |
Italy | IT005 | Palermo | |
Italy | IT007 | Palermo | |
Italy | IT307 | Perugia | |
Italy | IT301 | Pisa | |
Italy | IT305 | Roma | |
Italy | IT308 | Roma | |
Italy | IT304 | Torino | |
Italy | IT310 | Torrette | |
Korea, Republic of | KR303 | Busan | |
Korea, Republic of | KR301 | Incheon | |
Korea, Republic of | KR308 | Seongnam-si | |
Korea, Republic of | KR302 | Seoul | |
Korea, Republic of | KR304 | Seoul | |
Korea, Republic of | KR305 | Seoul | |
Korea, Republic of | KR306 | Seoul | |
Korea, Republic of | KR307 | Seoul | |
Korea, Republic of | KR309 | Seoul | |
Lithuania | LT302 | Kaunas | |
Lithuania | LT303 | Kaunas | |
Lithuania | LT301 | Vilnius | |
Lithuania | LT304 | Vilnius | |
Poland | PL301 | Bialystok | |
Poland | PL304 | Bydgoszcz | |
Poland | PL308 | Gdynia | |
Poland | PL004 | Gliwice | |
Poland | PL007 | Katowice | |
Poland | PL309 | Krakow | |
Poland | PL302 | Lodz | |
Poland | PL310 | Lubin | |
Poland | PL306 | Lublin | |
Poland | PL307 | Oswiecim | |
Poland | PL005 | Pozna | |
Poland | PL303 | Poznan | |
Poland | PL006 | Sopot | |
Poland | PL002 | Szczecin | |
Poland | PL311 | Szczecin | |
Poland | PL003 | Warszawa | |
Poland | PL008 | Wroclaw | |
Portugal | PT301 | Amadora | |
Portugal | PT302 | Coimbra | |
Romania | RO002 | Bucharest | |
Romania | RO001 | Târgu-Mures | |
South Africa | ZA003 | Bloemfontein | |
South Africa | ZA006 | Cape Town | |
South Africa | ZA007 | Cape Town | |
South Africa | ZA004 | George | |
South Africa | ZA001 | Pretoria | |
South Africa | ZA002 | Rosebank | |
Spain | ES006 | Barcelona | |
Spain | ES005 | Manresa | |
Spain | ES004 | Salamanca | |
Spain | ES001 | San Sebastian | |
Spain | ES002 | San Vicente del Raspeig | |
Spain | ES003 | Santiago de Compostela | |
Taiwan | TW301 | Kaohsiung | |
Taiwan | TW302 | Kaohsiung | |
Taiwan | TW303 | Tainan | |
Ukraine | UA008 | Dnipropetrovsk | |
Ukraine | UA006 | Kherson | |
Ukraine | UA005 | Kyiv | |
Ukraine | UA007 | Kyiv | |
Ukraine | UA001 | Lviv | |
United Kingdom | GB307 | Amersham | |
United Kingdom | GB301 | Glasgow | |
United Kingdom | GB303 | London | |
United Kingdom | GB308 | London | |
United Kingdom | GB310 | London | |
United Kingdom | GB306 | Plymouth | |
United Kingdom | GB311 | Plymouth | |
United Kingdom | GB309 | Prescot | |
United Kingdom | GB305 | Preston | |
United Kingdom | GB304 | Southampton | |
United Kingdom | GB302 | Swindon | |
United States | US047 | Arlington | Virginia |
United States | US304 | Atlanta | Georgia |
United States | US360 | Augusta | Georgia |
United States | US027 | Birmingham | Alabama |
United States | US344 | Boston | Massachusetts |
United States | US021 | Bradenton | Florida |
United States | US050 | Brooksville | Florida |
United States | US351 | Carlsbad | California |
United States | US007 | Centerville | Ohio |
United States | US316 | Charlotte | North Carolina |
United States | US030 | Chicago | Illinois |
United States | US323 | Cincinnati | Ohio |
United States | US006 | Columbus | Ohio |
United States | US306 | Columbus | Ohio |
United States | US356 | Cordova | Tennessee |
United States | US346 | Costa Mesa | California |
United States | US308 | Delray Beach | Florida |
United States | US041 | Flowood | Mississippi |
United States | US343 | Fort Worth | Texas |
United States | US036 | Freeport | Maine |
United States | US327 | Fullerton | California |
United States | US320 | Hallandale Beach | Florida |
United States | US321 | Hattiesburg | Mississippi |
United States | US347 | Hialeah | Florida |
United States | US354 | Houston | Texas |
United States | US023 | Imperial | California |
United States | US040 | Indianapolis | Indiana |
United States | US057 | Jenkintown | Pennsylvania |
United States | US048 | Kailua | Hawaii |
United States | US035 | Kalamazoo | Michigan |
United States | US334 | Lake Charles | Louisiana |
United States | US340 | Lake Worth | Florida |
United States | US352 | Lakewood | Ohio |
United States | US024 | Little Rock | Arkansas |
United States | US045 | Long Beach | California |
United States | US025 | Madison | Wisconsin |
United States | US339 | Manchester | New Jersey |
United States | US014 | Manhasset | New York |
United States | US303 | Miami | Florida |
United States | US313 | Miami | Florida |
United States | US004 | Milwaukee | Wisconsin |
United States | US029 | New York | New York |
United States | US333 | Oklahoma City | Oklahoma |
United States | US345 | Orange City | Florida |
United States | US019 | Orlando | Florida |
United States | US309 | Palm Beach Gardens | Florida |
United States | US012 | Phoenix | Arizona |
United States | US338 | Phoenix | Arizona |
United States | US324 | Pittsburgh | Pennsylvania |
United States | US341 | Pittsburgh | Pennsylvania |
United States | US038 | Port Charlotte | Florida |
United States | US319 | Port Royal | South Carolina |
United States | US026 | Portland | Oregon |
United States | US046 | Princeton | New Jersey |
United States | US307 | Redlands | California |
United States | US310 | Saint Paul | Minnesota |
United States | US058 | San Francisco | California |
United States | US018 | Santa Ana | California |
United States | US301 | Santa Rosa | California |
United States | US312 | Staten Island | New York |
United States | US302 | Sunrise | Florida |
United States | US028 | Toms River | New Jersey |
United States | US044 | Toms River | New Jersey |
United States | US336 | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
H. Lundbeck A/S |
United States, Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Lithuania, Poland, Portugal, Romania, South Africa, Spain, Taiwan, Ukraine, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Treatment Emergent Adverse Events (TEAEs) in the OLEX | A TEAE is an adverse event that starts or increases in intensity after the date of Baseline II. | Baseline II (start of OLEX, week 0) to end of OLEX (week 28) | |
Primary | Number of TEAEs in the OLEX-MEM | A TEAE is an adverse event that starts or increases in intensity after the date of Baseline III (start of OLEX-MEM). | From Baseline III (start of OLEX-MEM, Week 28) to end of OLEX-MEM (Week 52) | |
Secondary | Change in Cognition | 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). | Baseline II (start of OLEX, Week 0) to Week 28 | |
Secondary | Clinical Global Impression Score | 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). | Week 28 | |
Secondary | Change in Daily Functioning | 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). | Baseline II (start of OLEX, Week 0) to Week 28 | |
Secondary | Change in Behavioural Disturbance | 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). | Baseline II (start of OLEX, Week 0) to Week 28 | |
Secondary | Change in Cognitive Aspects of Mental Function | 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). | Baseline II (start of OLEX, Week 0) to Week 28 | |
Secondary | Change in Cognitive Aspects of Mental Function | 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). | Baseline III (start of OLEX-MEM, Week 28) to Week 52 |
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