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

NCT01766336 | Terminated Phase 2 Results

• 2 other identifiers: ELND005-AG2512012-005524-15
• Study Type: interventional
• Target: 296
• Locations: 4 countries
• Sites: 46

Brief Summary

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.

Conditions

Alzheimer's Disease

Keywords

Agitation; Aggression; AD patients

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Interventions

Group 1 ELND005 DRUG

Group 1 ELND005/ELND005

Group 2 ELND005 DRUG

Group 2 PLACEBO/ELND005

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Complete Week 12 visit of AG201
• Both patient and study partner/caregiver are willing and able to participate in all scheduled evaluations and complete all required tests

You may not qualify if:

• Is currently using any other investigational or experimental drugs or devices
• Has significant worsening of medical conditions or dementia such that it may preclude completion of this safety extension study

Sponsors & Collaborators

• OPKO Health, Inc.: lead
• Elan Pharmaceuticals: collaborator

Study Sites (46)

TransitionTIL Investigational Site

Birmingham, Alabama, 35294, United States

Location

TransitionTIL Investigational Site

Phoenix, Arizona, 85004, United States

Location

TransitionTIL Investigational Site

Phoenix, Arizona, 85006, United States

Location

TransitionTIL Investigational Site

Encino, California, 91316, United States

Location

TransitionTIL Investigational Site

Escondido, California, 92025, United States

Location

TransitionTIL Investigational Site

Fresno, California, 93710, United States

Location

TransitionTIL Investigational Site

Long Beach, California, 90806, United States

Location

TransitionTIL Investigational Site

Newport Beach, California, 92658, United States

Location

TransitionTIL Investigational Site

Orange, California, 92868, United States

Location

TransitionTIL Investigational Site

Norwalk, Connecticut, 06851, United States

Location

TransitionTIL Investigational Site

Washington D.C., District of Columbia, 20057, United States

Location

TransitionTIL Investigational Site

Atlantis, Florida, 33462, United States

Location

TransitionTIL Investigational Site

Deerfield Beach, Florida, 33064, United States

Location

TransitionTIL Investigational Site

Delray Beach, Florida, 33445, United States

Location

TransitionTIL Investigational Site

Lake Worth, Florida, 33449, United States

Location

TransitionTIL Investigational Site

Oakland Park, Florida, 33334, United States

Location

TransitionTIL Investigational Site

Orlando, Florida, 32806, United States

Location

TransitionTIL Investigational Site

Port Charlotte, Florida, 33952, United States

Location

TransitionTIL Investigational Site

Sarasota, Florida, 34243, United States

Location

TransitionTIL Investigational Site

Columbus, Georgia, 31909, United States

Location

TransitionTIL Investigational Site

Savannah, Georgia, 31419, United States

Location

TransitionTIL Investigational Site

Springfield, Illinois, 62702, United States

Location

TransitionTIL Investigational Site

Easton, Maryland, 21601, United States

Location

TransitionTIL Investigational Site

Winchester, Massachusetts, 01890, United States

Location

TransitionTIL Investigational Site

Saint Paul, Minnesota, 55130, United States

Location

TransitionTIL Investigational Site

Rochester, New York, 14620, United States

Location

TransitionTIL Investigational Site

Rochester, New York, 14623, United States

Location

TransitionTIL Investigational Site

Charlotte, North Carolina, 28211, United States

Location

TransitionTIL Investigational Site

Durham, North Carolina, 27710, United States

Location

TransitionTIL Investigational Site

Wilmington, North Carolina, 28401, United States

Location

TransitionTIL Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

TransitionTIL Investigational Site

Oklahoma City, Oklahoma, 73112, United States

Location

TransitionTIL Investigational Site

Portland, Oregon, 97225-6625, United States

Location

TransitionTIL Investigational Site

Abington, Pennsylvania, 19001, United States

Location

TransitionTIL Investigational Site

Jenkintown, Pennsylvania, 19046, United States

Location

TransitionTIL Investigational Site

Norristown, Pennsylvania, 19401, United States

Location

TransitionTIL Investigational Site

Pittsburgh, Pennsylvania, 15213, United States

Location

TransitionTIL Investigational Site

Port Royal, South Carolina, 29935, United States

Location

TransitionTIL Investigational Site

DeSoto, Texas, 75115, United States

Location

TransitionTIL Investigational Site

Bellevue, Washington, 98007, United States

Location

TransitionTIL Investigational Site

Toronto, Ontario, M6M 3Z5, Canada

Location

TransitionTIL Investigational Site

Elche, Alicante, 03203, Spain

Location

TransitionTIL Investigational Site

Terrassa, Barcelona, 08221, Spain

Location

TransitionTIL Investigational Site

Barcelona, 08028, Spain

Location

TransitionTIL Investigational Site

Madrid, 28040, Spain

Location

TransitionTIL Investigational Site

Swindon, Wiltshire, SN3 6BW, United Kingdom

Location

MeSH Terms

Conditions

Alzheimer Disease; Psychomotor Agitation; Aggression

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Results Point of Contact

• Title: Aleksandar Pastrak, MD, PhD, Vice President Clinical Development
• Organization: Transition Therapeutics Ireland Limited

apastrak@transitiontherapeutics.com

+1 416 263 1227

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2013
• First Posted: January 11, 2013
• Study Start: January 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 21, 2019
• Results First Posted: May 13, 2016

Record last verified: 2019-10

Locations

US (40); CA (1); GB (1); ES (4)