Long-term Safety and Tolerability of Idalopirdine (Lu AE5... | NCT02079246

ID	Type	Description	Link
2013-000001-23	EudraCT Number

Label	Type	Description	Intervention Names
Idalopirdine (Lu AE58054) 60 mg	Experimental	Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.	Drug: Idalopirdine 60 mg
Idalopirdine 60 mg + memantine	Experimental	Idalopirdine 60 mg as adjunct to 10 mg donepezil and memantine (patient's individualised maintenance dose, either immediate-release (IR) 20 mg/day (recommended target dose) or extended release (XR) 28 mg/day (recommended target dose). Memantine was administered to approximately 100 patients included in the OLEX-MEM. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study. The dose of memantine could be changed at any time throughout the study.	Drug: Idalopirdine 60 mg

Name	Type	Description	Arm Group Labels	Other Names
Idalopirdine 60 mg	Drug	once daily, encapsulated tablets, orally	Idalopirdine (Lu AE58054) 60 mg Idalopirdine 60 mg + memantine

Measure	Description	Time Frame
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)
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)

Measure	Description	Time Frame
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).

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

ID	Title	Description
FG000	Idalopirdine 60 mg	Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.
FG001	Idalopirdine 60 mg + Memantine

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 16, 2015	Jun 14, 2018

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

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.

All patients who took at least one dose of IMP in the OLEX.

Posted

Number

TEAEs

Baseline II (start of OLEX, week 0) to end of OLEX (week 28)

ID	Title	Description
OG000	Idalopirdine 60 mg	Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.

Units	Counts
Participants	OG0001462

Title

Denominators

Categories

Title	Measurements
	OG0002130

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).

All patients who took at least one dose of IMP or memantine in the OLEX-MEM.

Posted

Number

TEAEs

From Baseline III (start of OLEX-MEM, Week 28) to end of OLEX-MEM (Week 52)

ID	Title	Description
OG000	Idalopirdine 60 mg + Memantine	Idalopirdine 60 mg as adjunct to 10 mg donepezil and memantine (patient's individualised maintenance dose, either immediate-release (IR) 20 mg/day (recommended target dose) or extended release (XR) 28 mg/day (recommended target dose). Memantine was administered to approximately 100 patients included in the OLEX-MEM. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study. The dose of memantine could be changed at any time throughout the study.

Units	Counts
Participants	OG000

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).

All patients in who took at least one dose of IMP in the OLEX.

Posted

Mean

Standard Error

units on a scale

Baseline II (start of OLEX, Week 0) to Week 28

ID	Title	Description
OG000	Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14681A	Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study. Patients from lead-in Study 14681A
OG001	Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14862A	Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study. Patients from lead-in Study 14682A

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).

All patients in who took at least one dose of IMP in the OLEX.

Posted

Mean

Standard Error

units on a scale

Week 28

ID	Title	Description
OG000	Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14681A	Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study. Patients from lead-in Study 14681A
OG001	Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14862A	Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study. Patients from lead-in Study 14682A

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).

All patients in who took at least one dose of IMP in the OLEX.

Posted

Mean

Standard Error

units on a scale

Baseline II (start of OLEX, Week 0) to Week 28

ID	Title	Description
OG000	Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14681A	Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study. Patients from lead-in Study 14681A
OG001	Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14862A	Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study. Patients from lead-in Study 14682A

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).

All patients in who took at least one dose of IMP in the OLEX.

Posted

Mean

Standard Error

units on a scale

Baseline II (start of OLEX, Week 0) to Week 28

ID	Title	Description
OG000	Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14681A	Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study. Patients from lead-in Study 14681A
OG001	Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14862A	Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study. Patients from lead-in Study 14682A

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).

All patients in who took at least one dose of IMP in the OLEX.

Posted

Mean

Standard Error

units on a scale

Baseline II (start of OLEX, Week 0) to Week 28

ID	Title	Description
OG000	Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14681A	Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study. Patients from lead-in Study 14681A
OG001	Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14862A	Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study. Patients from lead-in Study 14682A

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).

All patients who took at least one dose of IMP or memantine in the OLEX-MEM.

Posted

Mean

Standard Error

units on a scale

Baseline III (start of OLEX-MEM, Week 28) to Week 52

ID	Title	Description
OG000	Idalopirdine 60 mg + Memantine (OLEX-MEM)	Idalopirdine 60 mg as adjunct to 10 mg donepezil and memantine (patient's individualised maintenance dose, either immediate-release (IR) 20 mg/day (recommended target dose) or extended release (XR) 28 mg/day (recommended target dose). Memantine was administered to approximately 100 patients included in the OLEX-MEM. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study. The dose of memantine could be changed at any time throughout the study.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute coronary syndrome	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Angina pectoris	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Atrioventricular block	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Bradycardia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Cardiac arrest	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Myocardial infarction	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Cataract	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Iris adhesions	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Retinal detachment	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Retinopathy proliferative	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Colitis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Constipation	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Enteritis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Exercise tolerance decreased	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Pyrexia	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Bacteraemia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Diverticulitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Escherichia sepsis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Gastroenteritis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Gastrointestinal bacterial infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Hepatitis e	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Herpes zoster	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Influenza	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Lower respiratory tract infection bacterial	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0002 affected1,462 at risk EG0010 affected101 at risk
Lower respiratory tract infection viral	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Lung infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Otitis media	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Peritonitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Pneumonia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0003 affected1,462 at risk EG0010 affected101 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0004 affected1,462 at risk EG0010 affected101 at risk
Septic shock	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0002 affected1,462 at risk EG0010 affected101 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0002 affected1,462 at risk EG0010 affected101 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0006 affected1,462 at risk EG0010 affected101 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0002 affected1,462 at risk EG0010 affected101 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0002 affected1,462 at risk EG0010 affected101 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Blood creatinine increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Blood potassium decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Benign neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Benign neoplasm of cervix uteri	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected922 at risk EG0010 affected69 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Balance disorder	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Brain stem infarction	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Cerebral infarction	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Dementia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Dementia alzheimer's type	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected1,462 at risk EG0010 affected101 at risk
Dizziness	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Encephalopathy	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Intracranial haematoma	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected1,462 at risk EG0010 affected101 at risk
Loss of consciousness	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected1,462 at risk EG0011 affected101 at risk
Partial seizures	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Presyncope	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Psychomotor hyperactivity	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Seizure	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Syncope	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Device malfunction	Product Issues	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Abnormal behaviour	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Aggression	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected1,462 at risk EG0010 affected101 at risk
Agitation	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Anxiety	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Confusional state	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Delirium	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected1,462 at risk EG0010 affected101 at risk
Delusion	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Depressive symptom	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Grief reaction	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected1,462 at risk EG0010 affected101 at risk
Sleep disorder	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Urinary retention	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected1,462 at risk EG0010 affected101 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected540 at risk EG0010 affected32 at risk
Breast mass	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Laryngeal haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Social stay hospitalisation	Social circumstances	MedDRA 19.0	Systematic Assessment	EG0000 affected1,462 at risk EG0011 affected101 at risk
Cataract operation	Surgical and medical procedures	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected1,462 at risk EG0010 affected101 at risk

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

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Idalopirdine 60 mg	Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.	11	1,462	91	1,462	182	1,462
EG001	Idalopirdine 60 mg + Memantine	Idalopirdine 60 mg as adjunct to 10 mg donepezil and memantine (patient's individualised maintenance dose, either immediate-release (IR) 20 mg/day (recommended target dose) or extended release (XR) 28 mg/day (recommended target dose). Memantine was administered to approximately 100 patients included in the OLEX-MEM. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study. The dose of memantine could be changed at any time throughout the study.	0	101	2	101	7	101

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment		EG000105 affected1,462 at risk EG0016 affected101 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment		EG00080 affected1,462 at risk EG0011 affected101 at risk