A 36-Week Safety Extension Study of ELND005 as a Treatmen... | NCT01766336

NCT01766336

ID	Type	Description	Link
2012-005524-15	EudraCT Number

Status Module

Sponsor/Collaborators Module

Name	Class
Elan Pharmaceuticals	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1 ELND005/ELND005	Experimental	Patients who received ELND005 during Study AG201 will continue on the same maintenance dose for 36 weeks.	Drug: Group 1 ELND005
Group 2 PLACEBO/ELND005	Experimental	Patients who received placebo during Study AG201 will receive ELND005 at the same dosing regimen as the active group in Study AG201 for 36 weeks.	Drug: Group 2 ELND005

Name	Type	Description	Arm Group Labels	Other Names
Group 1 ELND005	Drug		Group 1 ELND005/ELND005
Group 2 ELND005

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Experiencing Treatment Emergent Adverse Events	To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure, in Moderate to Severe AD patients with agitation and aggression.	36 weeks

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
TransitionTIL Investigational Site		Birmingham	Alabama	35294	United States
TransitionTIL Investigational Site

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	ELND005/ELND005	Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251
FG001	Placebo/ELND005	Patients who received Placebo in AG201 and received ELND005 in this extension study AG251

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	ELND005/ELND005	Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251
BG001	Placebo/ELND005	Patients who received Placebo in AG201 and received ELND005 in this extension study AG251
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00076.6± 7.9 BG00175.9± 8.7 BG00276.2± 8.3

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00084 BG00181 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Asian

Title	Measurements
	BG0001 BG0011 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

North America

Title	Measurements
	BG000137 BG001134 BG002

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 Participants Experiencing Treatment Emergent Adverse Events

To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure, in Moderate to Severe AD patients with agitation and aggression.

Posted

Number

participants

36 weeks

ID	Title	Description
OG000	ELND005/ELND005	Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251
OG001	Placebo/ELND005	Patients who received Placebo in AG201 and received ELND005 in this extension study AG251

Units	Counts
Participants	OG000150 OG001146

Title

Denominators

Categories

Title	Measurements
	OG000105 OG00191

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	ELND005/ELND005	Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251			29	150	41	150
EG001	Placebo/ELND005	Patients who received Placebo in AG201 and received ELND005 in this extension study AG251			26	146	26	146

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Syncope	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0003 affected150 at risk EG0011 affected146 at risk
Dementia alzheimer's type	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected150 at risk EG0013 affected146 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected150 at risk EG0011 affected146 at risk
Ataxia	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected150 at risk EG0010 affected146 at risk
Brain hypoxia	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected150 at risk EG0010 affected146 at risk
Carotid Artery Stenosis	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected150 at risk EG0011 affected146 at risk
Convulsion	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected150 at risk EG0010 affected146 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected150 at risk EG0010 affected146 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected150 at risk EG0010 affected146 at risk
Mental status change	Psychiatric disorders	MedDRA (Unspecified)	Systematic Assessment	EG0003 affected150 at risk EG0013 affected146 at risk
Agitation	Psychiatric disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected150 at risk EG0013 affected146 at risk
Aggression	Psychiatric disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected150 at risk EG0010 affected146 at risk
Homocidial ideation	Psychiatric disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected150 at risk EG0011 affected146 at risk
Behavioural and psychiatric symptoms of dementia	Psychiatric disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected150 at risk EG0010 affected146 at risk
Psychotic disorder	Psychiatric disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected150 at risk EG0011 affected146 at risk
Pneumonia	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0003 affected150 at risk EG0011 affected146 at risk
Bronchitis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected150 at risk EG0011 affected146 at risk
Diverticulitis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected150 at risk EG0011 affected146 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected150 at risk EG0011 affected146 at risk
Influenza	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected150 at risk EG0011 affected146 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected150 at risk EG0011 affected146 at risk
Cardiac arrest	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected150 at risk EG0012 affected146 at risk
Myocardial infarction	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected150 at risk EG0011 affected146 at risk
Coronary artery disease	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected150 at risk EG0011 affected146 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected150 at risk EG0010 affected146 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected150 at risk EG0010 affected146 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected150 at risk EG0011 affected146 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected150 at risk EG0010 affected146 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected150 at risk EG0010 affected146 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected150 at risk EG0010 affected146 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected150 at risk EG0011 affected146 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected150 at risk EG0011 affected146 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected150 at risk EG0011 affected146 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected150 at risk EG0011 affected146 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected150 at risk EG0011 affected146 at risk
Gastritis	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected150 at risk EG0010 affected146 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected150 at risk EG0011 affected146 at risk
Death	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected150 at risk EG0010 affected146 at risk
General physical health deterioriation	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected150 at risk EG0010 affected146 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected150 at risk EG0010 affected146 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected150 at risk EG0010 affected146 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected150 at risk EG0010 affected146 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected150 at risk EG0011 affected146 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected150 at risk EG0010 affected146 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected150 at risk EG0010 affected146 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected150 at risk EG0011 affected146 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected150 at risk EG0011 affected146 at risk
Hypotension	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected150 at risk EG0010 affected146 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Agitation	Psychiatric disorders	MedDRA (Unspecified)	Systematic Assessment	EG00015 affected150 at risk EG00114 affected146 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG00020 affected150 at risk EG0017 affected146 at risk
Urinary tract infection	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG00014 affected150 at risk EG0017 affected146 at risk

Point of Contact

Title	Organization	Phone	Extension	Email
Aleksandar Pastrak, MD, PhD, Vice President Clinical Development	Transition Therapeutics Ireland Limited	+1 416 263 1227		apastrak@transitiontherapeutics.com

ID	Term
D000544	Alzheimer Disease
D011595	Psychomotor Agitation
D000374	Aggression

Ancestor Terms

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
D020820	Dyskinesias
D009461	Neurologic Manifestations
D011596	Psychomotor Disorders
D019954	Neurobehavioral Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D000096762	Aberrant Motor Behavior in Dementia
D001526	Behavioral Symptoms
D001519	Behavior
D012919	Social Behavior