NCT01735630|CompletedPhase 2Results

Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Efficacy and Safety Study of Oral ELND005 for Treatment of Agitation and Aggression in Patients With Moderate to Severe Alzheimer's Disease

OPKO Health, Inc.ClinicalTrials.gov

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2 other identifiers

ELND005-AG2012012-004299-20

Study Type

interventional

Target

350

Locations

4 countries

Sites

Timeline

RegisteredNov 2012

StartedNov 2012

CompletionMay 2015

Brief Summary

The primary purpose of this study is to determine whether ELND005 is effective in treating symptoms of agitation and aggression in patients with Alzheimer's disease

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

350

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Nov 2012

Geographic Reach

4 countries

70 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.5 years study duration

Study Start

First participant enrolled

November 1, 2012

Completed

24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2012

Completed

3 days until next milestone

First Posted

Study publicly available on registry

November 28, 2012

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

August 15, 2016

Completed

Last Updated

October 21, 2019

Status Verified

October 1, 2019

Enrollment Period

2.5 years

First QC Date

November 25, 2012

Results QC Date

April 7, 2016

Last Update Submit

October 17, 2019

Conditions

Alzheimer's Disease

Keywords

AgitationAggressionpatients

Outcome Measures

Primary Outcomes (1)

Change From Baseline in NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A).
The NPI-C (de Medeiros et al 2010) is a validated and reliable behavioral measure that assesses psychopathology in dementia subjects. It evaluates 14 neuropsychiatric disturbances common in dementia.Higher scores on the NPI-C are associated with a greater clinical severity of symptoms. The NPI-C Agitation and Aggression score ranges from 0-63. The analysis of the NPI-C A+A score was performed on the mITT population.
Week 12

Secondary Outcomes (4)

Change From Baseline in Modified-ADCS-CGIC Agitation Scores
Week 12
Change From Baseline in NPI Total Scores
Week 12
Change From Baseline in MMSE Scores
Week 12
Change From Baseline in ADCS-ADL Scores
Week 12

Study Arms (2)

ELND005

EXPERIMENTAL

ELND005 film coated tablets, BID for 12 weeks

Drug: ELND005

Placebo

PLACEBO COMPARATOR

Matched placebo BID for 12 weeks

Drug: Placebo

Interventions

ELND005DRUG

Also known as: Scyllo-inositol

ELND005

PlaceboDRUG

Placebo

Eligibility Criteria

Age50 Years - 95 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Diagnosis of Probable AD according to the National Institute on Aging- Alzheimer's Association (NIA-AA) guidelines (McKhann et al 2011).
MMSE score of 5 to 24 (inclusive) at the Screening Visit.
Has clinically significant agitation/aggression defined as Neuropsychiatric Inventory (NPI)-agitation/aggression subscore of ≥4.
No response or suboptimal response to standard nonpharmacological interventions.

You may not qualify if:

The agitation/aggression is attributable to concomitant medications, environmental conditions, or active medical or psychiatric condition.
Current diagnosis of major depressive disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision (DSM IV TR).
Has persistent and distressing psychotic symptoms (delusion and/or hallucinations) that require psychiatric hospitalization.

Contact the study team to confirm eligibility.