Alzheimer's Disease Clinical Trial
— STARBRIGHTOfficial title:
Randomised, Double-blind, Parallel-group, Placebo-controlled Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor
Verified date | January 2018 |
Source | H. Lundbeck A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To establish efficacy of idalopirdine as adjunctive therapy to acetylcholinesterase inhibitors (AChEIs) for symptomatic treatment of patients with mild-moderate Alzheimer's disease (AD).
Status | Completed |
Enrollment | 734 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - 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 an AChEI. - 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. Exclusion Criteria: - 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 current AChEI 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. |
Country | Name | City | State |
---|---|---|---|
Australia | AU603 | Caulfield | |
Australia | AU609 | Glen Iris | |
Australia | AU602 | Heidelberg West | |
Australia | AU604 | Kanwal | |
Australia | AU606 | Newcastle | |
Australia | AU601 | West Perth | |
Australia | AU610 | Woodville south | |
Brazil | BR608 | Belo Horizonte | |
Brazil | BR609 | Itapira | |
Brazil | BR607 | Rio de Janeiro | |
Czechia | CZ602 | Chocen | |
Czechia | CZ608 | Chocen | |
Czechia | CZ605 | Havlickuv Brod | |
Czechia | CZ606 | Kladno | |
Czechia | CZ603 | Plzen | |
Czechia | CZ601 | Prague | |
Czechia | CZ607 | Praha 10 - Strasnice | |
Czechia | CZ604 | Praha 6 | |
Germany | DE612 | Bad Homburg | |
Germany | DE610 | Bad Honnef | |
Germany | DE609 | Berlin | |
Germany | DE617 | Berlin | |
Germany | DE604 | Erbach | |
Germany | DE611 | Freiburg | |
Germany | DE607 | Gelsenkirchen | |
Germany | DE605 | Homburg | |
Germany | DE608 | Karlstadt | |
Germany | DE602 | Mittweida | |
Germany | DE601 | Munich | |
Germany | DE606 | Rostock | |
Germany | DE603 | Ulm | |
Germany | DE616 | Unterhaching | |
Israel | IL605 | Bat Yam | |
Israel | IL601 | Haifa | |
Israel | IL604 | Holon | |
Israel | IL602 | Ramat Gan | |
Israel | IL603 | Tel Aviv | |
Korea, Republic of | KR601 | Seongnam-si | |
Korea, Republic of | KR602 | Seoul | |
Korea, Republic of | KR603 | Seoul | |
Korea, Republic of | KR604 | Seoul | |
Mexico | MX602 | Mexico | |
Mexico | MX601 | Monterrey | |
Mexico | MX603 | Monterrey | |
Mexico | MX604 | Monterrey | |
Mexico | MX605 | Monterrey | |
Mexico | MX606 | Saltillo | |
Serbia | RS602 | Belgrade | |
Serbia | RS603 | Kragujevac | |
Serbia | RS601 | Novi Sad | |
Singapore | SG601 | Singapore | |
Singapore | SG602 | Singapore | |
Slovakia | SK601 | Banska Bystrica | |
Slovakia | SK603 | Bratislava | |
Slovakia | SK605 | Bratislava | |
Slovakia | SK604 | Rimavska Sobota | |
Slovakia | SK602 | Svidnik | |
Spain | ES601 | Barcelona | |
Spain | ES603 | Barcelona | |
Spain | ES604 | Barcelona | |
Spain | ES608 | Barcelona | |
Spain | ES611 | Bilbao | |
Spain | ES612 | Burgos | |
Spain | ES602 | Lleida | |
Spain | ES613 | Madrid | |
Spain | ES610 | Sant Cugat del Vallès | |
Spain | ES606 | Sevilla | |
Spain | ES605 | Terrassa | |
Spain | ES607 | Valencia | |
Switzerland | CH603 | Biel | |
Switzerland | CH605 | Lausanne | |
Switzerland | CH602 | Les Acacias | |
Switzerland | CH601 | Schlieren | |
Turkey | TR602 | Balova | |
Turkey | TR601 | Istanbul | |
Turkey | TR603 | Istanbul | |
Turkey | TR605 | Istanbul | |
Turkey | TR606 | Izmir | |
Turkey | TR607 | Samsun | |
United Kingdom | GB601 | Brentford | |
United Kingdom | GB603 | Northampton | |
United States | US621 | Albany | New York |
United States | US625 | Bellflower | California |
United States | US633 | Charlotte | North Carolina |
United States | US626 | Costa Mesa | California |
United States | US609 | Danbury | Connecticut |
United States | US608 | Deerfield Beach | Florida |
United States | US622 | Elk Grove Village | Illinois |
United States | US611 | Elkhart | Indiana |
United States | US601 | Farmington Hills | Michigan |
United States | US616 | Hialeah | Florida |
United States | US619 | Houston | Texas |
United States | US613 | Lawrenceville | New Jersey |
United States | US635 | Manchester | New Jersey |
United States | US612 | Mesa | Arizona |
United States | US620 | Miami | Florida |
United States | US618 | Norristown | Pennsylvania |
United States | US603 | North Palm Beach | Florida |
United States | US614 | Norwalk | Connecticut |
United States | US623 | Oklahoma City | Oklahoma |
United States | US604 | Oxnard | California |
United States | US631 | Port Charlotte | Florida |
United States | US606 | Prairie Village | Kansas |
United States | US607 | Saint Louis | Missouri |
United States | US627 | Santa Ana | California |
United States | US632 | Staten Island | New York |
United States | US630 | Toms River | New Jersey |
Lead Sponsor | Collaborator |
---|---|
H. Lundbeck A/S | Otsuka Pharmaceutical Co., Ltd. |
United States, Australia, Brazil, Czechia, Germany, Israel, Korea, Republic of, Mexico, Serbia, Singapore, Slovakia, Spain, Switzerland, Turkey, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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). |
Baseline and Week 24 | |
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). |
Baseline and Week 24 | |
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). |
Baseline and Week 24 | |
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 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 NPI score is the frequency ratings multiplied by the severity ratings and ranges from 0 to 144 (higher score indicates worse outcome). |
Baseline and Week 24 | |
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. |
Baseline and Week 24 | |
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. |
Baseline and Week 24 | |
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]) | Week 24 | |
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]) | Week 24 | |
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). |
Baseline and Week 24 | |
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. |
Baseline and 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). |
Baseline and Week 24 |
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