← Back to Search

Other

AVP-786 for Alzheimer's-related Agitation

Verified Trial
Phase 3
Recruiting
Research Sponsored by Avanir Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with a diagnosis of probable Alzheimer's disease according to the 2011 Neuropsychiatric Inventory Agitation/Aggression (NPI-AA) working groups criteria
Diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; week 12
Awards & highlights

Study Summary

This trial will test whether AVP-786 is better than placebo at treating Alzheimer's-related agitation.

Who is the study for?
This trial is for people with Alzheimer's who show moderate-to-severe agitation. They must have been diagnosed according to specific criteria, need medication as judged by a doctor, and have had non-drug treatments tried first. A reliable caregiver must be involved. Those with non-Alzheimer's dementia or conditions like myasthenia gravis can't join.Check my eligibility
What is being tested?
The study tests AVP-786 against a placebo to see if it helps calm agitation in Alzheimer's patients better than no treatment at all. Participants will not know whether they're getting the real medicine or the placebo.See study design
What are the potential side effects?
While the side effects of AVP-786 are not detailed here, similar medications often cause dizziness, headache, nausea, and sometimes more serious effects like heart problems or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Alzheimer's disease based on specific criteria.
Select...
My agitation is officially recognized by a major health organization.
Select...
I have a caregiver who can help me with my treatment and follows the study rules.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score
Secondary outcome measures
Change from Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGI-S) Score, as Related to Agitation

Side effects data

From 2019 Phase 3 trial • 387 Patients • NCT02442765
8%
Fall
4%
Diarrhoea
4%
Agitation
3%
Urinary tract infection
3%
Dizziness
3%
Somnolence
2%
Upper respiratory tract infection
2%
Arthralgia
2%
Electrocardiogram QT prolonged
2%
Nasopharyngitis
2%
Skin abrasion
1%
Tendonitis
1%
Deep vein thrombosis
1%
Poor dental condition
1%
Fungal infection
1%
Ligament sprain
1%
Rib fracture
1%
Flank pain
1%
Muscle spasms
1%
Sinus arrhythmia
1%
Fatigue
1%
Malaise
1%
Lethargy
1%
Insomnia
1%
Aggression
1%
Rash
1%
Headache
1%
White blood cells urine positive
1%
Hot flush
1%
Hypertension
1%
Pulmonary embolism
1%
Arthritis
1%
Neck pain
1%
Foot fracture
1%
Malnutrition
1%
Bradycardia
1%
Diplopia
1%
Constipation
1%
Laceration
1%
Muscle rupture
1%
Coronary artery disease
1%
Tinnitus
1%
Eye allergy
1%
Contusion
1%
Spinal compression fracture
1%
Influenza like illness
1%
Non-cardiac chest pain
1%
Influenza
1%
Cellulitis
1%
Muscle strain
1%
Decreased appetite
1%
Synovitis
1%
Hallucination
1%
Hypnopompic hallucination
1%
Asthma
1%
Chronic obstructive pulmonary disease
1%
Haematoma
1%
Eczema
1%
Leukocytosis
1%
Neutrophil count increased
1%
Blood pressure increased
1%
Glycosylated haemoglobin increased
1%
Iron deficiency anaemia
1%
Diverticulum
1%
Gastroenteritis
1%
White blood cell count increased
1%
Acne
1%
Sinus bradycardia
1%
Ventricular extrasystoles
1%
Bundle branch block left
1%
Dyspepsia
1%
Sinusitis
1%
Pneumonia
1%
Acute kidney injury
1%
Abdominal pain
1%
Gastrooesophageal reflux disease
1%
Toothache
1%
Anal fissure
1%
Feeling cold
1%
Animal scratch
1%
Arthropod bite
1%
Type 2 diabetes mellitus
1%
Osteoarthritis
1%
Back pain
1%
Musculoskeletal chest pain
1%
Musculoskeletal pain
1%
Skin cancer
1%
Syncope
1%
Decreased vibratory sense
1%
Hyperreflexia
1%
Presyncope
1%
Abnormal behaviour
1%
Abnormal dreams
1%
Nephrolithiasis
1%
Pulmonary mass
100%
80%
60%
40%
20%
0%
Study treatment Arm
AVP-786-28
Placebo
AVP-786-18

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AVP-786Experimental Treatment1 Intervention
Participants will be assigned to treatment with AVP-786 capsules administered twice a day over a 12-week period.
Group II: PlaceboPlacebo Group1 Intervention
Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AVP-786
2017
Completed Phase 3
~1340

Find a Location

Who is running the clinical trial?

Avanir PharmaceuticalsLead Sponsor
31 Previous Clinical Trials
12,451 Total Patients Enrolled
Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
245 Previous Clinical Trials
166,245 Total Patients Enrolled

Media Library

AVP-786 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04464564 — Phase 3
Agitation in Dementia Research Study Groups: Placebo, AVP-786
Agitation in Dementia Clinical Trial 2023: AVP-786 Highlights & Side Effects. Trial Name: NCT04464564 — Phase 3
AVP-786 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04464564 — Phase 3
Agitation in Dementia Patient Testimony for trial: Trial Name: NCT04464564 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment have an age limit?

"This trial only accepts patients that are between 50 and 90 years old. In contrast, there are 45 clinical trials for children and 770 trials for senior citizens."

Answered by AI

When might AVP-786 be cleared for public distribution by the FDA?

"AVP-786 falls into the Phase 3 category, which means that while there is some data supporting efficacy, there is also a fair amount of data that supports safety. We believe that AVP-786 is safe and gave it a score of 3."

Answered by AI

At how many hospitals is this experiment being conducted?

"This study is currently enrolling patients at 39 different locations, including Clinical Research Site #840-049 in West Palm Beach, Clinical Research Site #840-046 in Los Angeles, and Clinical Research Site #840-066 in San Diego."

Answered by AI

If I wanted to join this research project, would that be possible?

"This trial, which is looking for 750 total participants, is currently enrolling individuals that are between the ages of 50 and 90 and have a dementia diagnosis. Additionally, patients must meet the following conditions: have probable Alzheimer's disease according to the 2011 NPI-AA working group criteria, have moderate-to-severe agitation that interferes with their day-to-day life for at least 2 weeks, require pharmacotherapy for agitation after other interventions have failed, meet the IPA provisional definition of agitation, meet a predetermined blinded eligibility criterion, have a caregiver who is willing and able to help with study procedures, spends 2+ hours per"

Answered by AI

Is it possible to still join this clinical trial?

"Yes. The clinical trial is recruiting participants at the moment. The study was posted on 2020-09-03 and was last edited on 2022-10-26. They are looking for 750 participants total, with recruitment happening at 39 different locations."

Answered by AI

How many people are undergoing this trial?

"In order to run this trial, we need 750 individuals who fit the specific bill. These people can be sourced from different clinical research sites, like #840-049 in West Palm Beach, Florida, and #840-046 in Los Angeles, California."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
Other
California
Florida
How old are they?
65+
What site did they apply to?
Clinical Research Site
Clinical Research Site - Bradenton
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
1

Why did patients apply to this trial?

I hat no try any drugs. I’ve tried 2 other drugs that have not given me any relief.
PatientReceived 1 prior treatment
I have been in two other AD trials at MGB over the past three years and now want to enter another AD trial.
PatientReceived no prior treatments
My name is Karen R Thomas. My Mother is the person that I am attempting to get in to your study. She will be 93 next week. PLEASE consider her in your research trial. She has only showed signs of dementia in the last 2.5 yrs. Still living independently with her husband of 15 years. She is educated, articulate, and so much more. She broke her hip and she was in rehab during the outbreak of COVID. I have been a RN for 40 years and practiced in several areas. They were having her Baker Acted while in rehab and I brought her and her husband to my home to live with me. AND did all her therapy. I worked in ortho for many years and rehab as well. She was somewhat confused at that time when I realized that they were not administering her Pristiq or her Klonopin 0.5mg prn. They were giving her Ativan which we are very much aware of the possible side effects in the elderly.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Clinical Research Site - Bradenton: < 24 hours
  2. Clinical Research Site: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
2020. "Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04464564.
All > Alzheimers Disease Dallas
~118 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top