Trial Outcomes & Findings for A 36-Week Safety Extension Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease (NCT NCT01766336)

Last Updated: 2019-10-21

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

296 participants

Primary outcome timeframe

36 weeks

Results posted on

2019-10-21

Participant Flow

Participant milestones

Participant milestones
Measure	ELND005/ELND005 Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251	Placebo/ELND005 Patients who received Placebo in AG201 and received ELND005 in this extension study AG251
Overall Study STARTED	150	146
Overall Study COMPLETED	60	71
Overall Study NOT COMPLETED	90	75

Reasons for withdrawal

Reasons for withdrawal
Measure	ELND005/ELND005 Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251	Placebo/ELND005 Patients who received Placebo in AG201 and received ELND005 in this extension study AG251
Overall Study Adverse Event	11	8
Overall Study Death	4	3
Overall Study Lost to Follow-up	1	3
Overall Study Physician Decision	4	2
Overall Study Protocol Violation	0	1
Overall Study Sponsor Decision	52	43
Overall Study Withdrawal by Subject	18	15

Baseline Characteristics

A 36-Week Safety Extension Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ELND005/ELND005 n=150 Participants Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251	Placebo/ELND005 n=146 Participants Patients who received Placebo in AG201 and received ELND005 in this extension study AG251	Total n=296 Participants Total of all reporting groups
Age, Continuous	76.6 years STANDARD_DEVIATION 7.9 • n=5 Participants	75.9 years STANDARD_DEVIATION 8.7 • n=7 Participants	76.2 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	84 Participants n=5 Participants	81 Participants n=7 Participants	165 Participants n=5 Participants
Sex: Female, Male Male	66 Participants n=5 Participants	65 Participants n=7 Participants	131 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	10 participants n=5 Participants	17 participants n=7 Participants	27 participants n=5 Participants
Race/Ethnicity, Customized White	138 participants n=5 Participants	127 participants n=7 Participants	265 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment North America	137 participants n=5 Participants	134 participants n=7 Participants	271 participants n=5 Participants
Region of Enrollment Europe	13 participants n=5 Participants	12 participants n=7 Participants	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 36 weeks

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.

Outcome measures

Outcome measures
Measure	ELND005/ELND005 n=150 Participants Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251	Placebo/ELND005 n=146 Participants Patients who received Placebo in AG201 and received ELND005 in this extension study AG251
Number of Participants Experiencing Treatment Emergent Adverse Events	105 participants	91 participants

Adverse Events

ELND005/ELND005

Serious events: 29 serious events

Other events: 41 other events

Deaths: 0 deaths

Placebo/ELND005

Serious events: 26 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	ELND005/ELND005 n=150 participants at risk Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251	Placebo/ELND005 n=146 participants at risk Patients who received Placebo in AG201 and received ELND005 in this extension study AG251
Psychiatric disorders Agitation	10.0% 15/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	9.6% 14/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Injury, poisoning and procedural complications Fall	13.3% 20/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	4.8% 7/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Infections and infestations Urinary tract infection	9.3% 14/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	4.8% 7/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.

Additional Information

Aleksandar Pastrak, MD, PhD, Vice President Clinical Development

Transition Therapeutics Ireland Limited

Phone: +1 416 263 1227

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	ELND005/ELND005 n=150 participants at risk Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251	Placebo/ELND005 n=146 participants at risk Patients who received Placebo in AG201 and received ELND005 in this extension study AG251
Nervous system disorders Syncope	2.0% 3/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.68% 1/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Nervous system disorders Dementia alzheimer's type	0.00% 0/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	2.1% 3/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Nervous system disorders Transient ischaemic attack	0.67% 1/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.68% 1/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Nervous system disorders Ataxia	0.67% 1/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.00% 0/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Nervous system disorders Brain hypoxia	0.67% 1/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.00% 0/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Nervous system disorders Carotid Artery Stenosis	0.00% 0/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.68% 1/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Nervous system disorders Convulsion	0.67% 1/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.00% 0/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Nervous system disorders Depressed level of consciousness	0.67% 1/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.00% 0/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Nervous system disorders Haemorrhage intracranial	0.67% 1/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.00% 0/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Psychiatric disorders Mental status change	2.0% 3/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	2.1% 3/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Psychiatric disorders Agitation	0.67% 1/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	2.1% 3/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Psychiatric disorders Aggression	0.67% 1/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.00% 0/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Psychiatric disorders Homocidial ideation	0.00% 0/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.68% 1/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Psychiatric disorders Behavioural and psychiatric symptoms of dementia	0.67% 1/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.00% 0/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Psychiatric disorders Psychotic disorder	0.00% 0/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.68% 1/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Infections and infestations Pneumonia	2.0% 3/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.68% 1/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Infections and infestations Bronchitis	0.67% 1/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.68% 1/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Infections and infestations Diverticulitis	0.00% 0/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.68% 1/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Infections and infestations Gastroenteritis viral	0.00% 0/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.68% 1/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Infections and infestations Influenza	0.00% 0/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.68% 1/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Cardiac disorders Atrial fibrillation	0.67% 1/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.68% 1/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Cardiac disorders Cardiac arrest	0.00% 0/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	1.4% 2/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Cardiac disorders Myocardial infarction	0.67% 1/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.68% 1/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Cardiac disorders Coronary artery disease	0.00% 0/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.68% 1/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Injury, poisoning and procedural complications Fall	1.3% 2/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.00% 0/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Injury, poisoning and procedural complications Femur fracture	1.3% 2/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.00% 0/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Injury, poisoning and procedural complications Hip fracture	0.67% 1/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.68% 1/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Injury, poisoning and procedural complications Femoral neck fracture	0.67% 1/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.00% 0/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Injury, poisoning and procedural complications Laceration	0.67% 1/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.00% 0/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.67% 1/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.00% 0/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.68% 1/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.68% 1/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.68% 1/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.68% 1/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.68% 1/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Gastrointestinal disorders Gastritis	1.3% 2/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.00% 0/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.68% 1/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
General disorders Death	0.67% 1/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.00% 0/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
General disorders General physical health deterioriation	0.67% 1/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.00% 0/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
General disorders Systemic inflammatory response syndrome	0.67% 1/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.00% 0/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Metabolism and nutrition disorders Failure to thrive	1.3% 2/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.00% 0/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Metabolism and nutrition disorders Dehydration	0.67% 1/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.00% 0/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Metabolism and nutrition disorders Hypophagia	0.00% 0/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.68% 1/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	1.3% 2/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.00% 0/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.67% 1/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.00% 0/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.68% 1/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.00% 0/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.68% 1/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.
Vascular disorders Hypotension	0.67% 1/150 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.	0.00% 0/146 • Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study.