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AVP-786 for Agitation in Alzheimer's Disease

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
Diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation.
Participants with a diagnosis of probable Alzheimer's disease according to the 2011 Neuropsychiatric Inventory Agitation/Aggression (NPI-AA) working groups criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; week 12
Awards & highlights

Study Summary

This trial will study whether AVP-786, a drug made of deudextromethorphan and quinidine, is better than placebo at treating agitation in people with Alzheimer's Disease.

Who is the study for?
This trial is for people with Alzheimer's who've had moderate-to-severe agitation for at least 2 weeks, affecting daily life. They need a reliable caregiver and must have tried non-drug therapies first. It's not for those with other types of dementia or agitation due to another condition, nor for those with serious health issues like uncontrolled diabetes or heart disease.Check my eligibility
What is being tested?
The study tests AVP-786 against a placebo to see if it can safely and effectively calm agitation in Alzheimer's patients. Participants will be randomly assigned to receive either the real drug or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
While specific side effects are not listed here, common concerns may include potential reactions related to the nervous system (like dizziness), gastrointestinal issues (such as nausea), and possible interactions with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My agitation is officially diagnosed according to the IPA standards.
Select...
I have been diagnosed with Alzheimer's disease.

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%
Arthralgia
2%
Electrocardiogram QT prolonged
2%
Nasopharyngitis
2%
Upper respiratory tract infection
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%
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%
Arthritis
1%
Neck pain
1%
Pulmonary embolism
1%
Sinus arrhythmia
1%
Muscle strain
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%
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

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

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
246 Previous Clinical Trials
166,299 Total Patients Enrolled

Media Library

AVP-786 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04408755 — Phase 3
Agitation in Dementia Research Study Groups: AVP-786, Placebo
AVP-786 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04408755 — Phase 3
Agitation in Dementia Patient Testimony for trial: Trial Name: NCT04408755 — Phase 3

Frequently Asked Questions

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

Would this particular test be appropriate for elderly individuals?

"This particular study only enrolls patients that are between 50 to 90 years old. In contrast, there are 46 clinical trials for minors and 785 for seniors."

Answered by AI

How many total participants are sought for this research project?

"Yes, the information on clinicaltrials.gov says that this clinical trial is presently recruiting participants. The trial was originally posted on 7/8/2020 and was most recently updated on 10/26/2022. The trial is searching for 750 participants at 34 locations."

Answered by AI

Are numerous hospitals in the United States participating in this trial?

"This trial is being conducted at 34 different centres, with notable locations including University of California in Irvine and Clinical Research Site #840-069 in Tampa."

Answered by AI

What is the regulatory body's opinion on AVP-786?

"AVP-786 is safe according to our internal metrics because it has progressed to Phase 3 testing. This means that, while more research needs to be done, there are promising signs of efficacy and the drug has undergone multiple rounds of safety testing."

Answered by AI

What are the requirements to participate in this experiment?

"This clinical trial is looking for 750 patients that suffer from alzheimer disease and are between the ages of 50-90. Furthermore, these patients must meet the following requirements: Be eligible for the study according to a predetermined criterion that will remain hidden from those conducting the study, Have a caregiver who is able and willing to help with administering medication and comply with other procedures, Spend at least 2 hours per day 4 days out of the week with the participant, Show moderate-to-severe agitation that gets in the way of their daily routine, Require pharmacotherapy to treat agitation after trying nonpharmacological interventions."

Answered by AI

Are patients currently being recruited for this clinical trial?

"Yes, this is an ongoing clinical trial that was initially posted on July 8th, 2020. The study is looking for 750 participants total, with recruitment happening at 34 different locations."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What site did they apply to?
Clinical Research Site
Other

Why did patients apply to this trial?

My father had dementia and alzheimers. I am very forgetful. My partner and caregiver, Richard Friede, has told me that I have gotten agitated at various times and I don't remember the events.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. Clinical Research Site: < 24 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Assessment of the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
2020. "Assessment of 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/NCT04408755.
All > Alzheimers Disease Miami
~113 spots leftby Dec 2024
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