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Treatment for Aggression and Agitation in Patients With Alzheimer's Disease | Clinical Trials | Clareo Health

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Treatment for Aggression and Agitation in Patients With Alzheimer's Disease

Assessment of LY451395 for Neuropsychiatric Symptoms of Aggression and Agitation in Alzheimer's Disease

NCT00843518•Eli Lilly and Company

Summary

The purpose of this study is to determine whether this drug can help symptoms of aggression and agitation in participants with Alzheimer's disease.

Detailed Description

The primary purpose of this study is to help answer the following research questions: * Whether this drug can help symptoms of aggression and agitation in participants with Alzheimer's Disease. * The safety of this drug and any side effects that might be associated with it. * How this drug compares to placebo. During the 12-week period of this study, the participant will have an equal chance of receiving 1 of the 2 treatment groups: active drug or placebo.

Eligibility

Age

60 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Community-dwelling participants with a diagnosis of probable Alzheimer's disease (AD) based on disease criteria from the National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and the Alzheimer's Association. Mini Mental State Examination (MMSE) score from 6 to 26 inclusive; Neuropsychiatric Inventory-10 (NPI-10) total score greater than or equal to 10.
•Are men or women at least 60 years old.
•Weight greater than or equal to 45 kilograms (kg).
•Have clinically significant and persistent verbal or physical agitation and/or verbal or physical aggression behaviors that are disruptive to daily functioning or potentially harmful and occurred at least 3 days per week over the past 4 weeks prior to study entry.
•Understand English.
•Have a reliable and actively involved caregiver who must be able to communicate in English and be willing to comply with protocol requirements.

Exclusion Criteria

•Meet DSM-IV-TR or Delirium Rating Scale-Revised-98 criteria for delirium.
•Does not score ≤4 on the Modified Hachinski Ischemia Scale for vascular dementia.
•Have a magnetic resonance imaging (MRI) or computer tomography (CT) scan on file since the onset of symptoms of AD and performed within the past 24 months that is inconsistent with a diagnosis of AD.
•Have a current, required use, or expected use of psychoactive drugs or other medications not allowed in this trial.
•Have currently active significant medical, neurological, or psychiatric problems that are not allowed in this trial or other brain disorders.
•Have received acetylcholinesterase inhibitor (AChEIs) or memantine for less than 4 months, or have less than 2 months of stable therapy on these treatments by Visit 2.

Locations (17)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Phoenix, Arizona, United States

Costa Mesa, California, United States

Hamden, Connecticut, United States

Orlando, Florida, United States

Tampa, Florida, United States

West Palm Beach, Florida, United States

Atlanta, Georgia, United States

Easton, Maryland, United States

Flowood, Mississippi, United States

Toms River, New Jersey, United States

Key Dates

Start Date

February 1, 2009

Primary Completion Date

June 1, 2011

Completion Date

June 1, 2011

Last Updated

November 29, 2017

Enrollment

132

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

LY451395

DRUG

Placebo

DRUG

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

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RECRUITING

Lombard Cohort of Brain Health Services

NCT07457138

Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 29, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Treatment for Aggression and Agitation in Patients With Alzheimer's Disease

Inclusion Criteria

Exclusion Criteria

ACP-204 in Adults With Alzheimer's Disease Psychosis

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