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AVP-786 for Agitation in Alzheimer's Disease
Phase 3
Waitlist Available
Research Sponsored by Avanir Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; week 12
Awards & highlights
Study Summary
This trial will compare the effectiveness of AVP-786 to a placebo in treating Alzheimer's patients who are experiencing agitation.
Who is the study for?
This trial is for adults with Alzheimer's Disease who have moderate to severe agitation that disrupts daily life. They must meet specific criteria for Alzheimer's diagnosis and agitation, have had these symptoms consistently for at least 2 weeks, and require medication. A caregiver must be present to assist and monitor changes, spending at least 2 hours a day with the participant.Check my eligibility
What is being tested?
The study tests AVP-786 against a placebo to see if it can safely and effectively treat agitation in Alzheimer’s patients. Participants will randomly receive either the actual drug or a placebo without knowing which one they are taking.See study design
What are the potential side effects?
While not specified here, side effects of AVP-786 may include dizziness, nausea, headache or other common drug reactions. The exact side effects will be monitored throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline; week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; week 12
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 (CGIS)-Agitation Domain Score
Side effects data
From 2019 Phase 3 trial • 387 Patients • NCT024427658%
Fall
4%
Diarrhoea
4%
Agitation
3%
Dizziness
3%
Urinary tract infection
3%
Somnolence
2%
Nasopharyngitis
2%
Skin abrasion
2%
Electrocardiogram QT prolonged
2%
Arthralgia
2%
Upper respiratory tract infection
1%
Hypnopompic hallucination
1%
Rib fracture
1%
Foot fracture
1%
Aggression
1%
Malaise
1%
Influenza
1%
Arthritis
1%
Bradycardia
1%
Sinus arrhythmia
1%
Constipation
1%
Fatigue
1%
Ligament sprain
1%
Contusion
1%
Muscle rupture
1%
Malnutrition
1%
Pulmonary embolism
1%
Tendonitis
1%
Deep vein thrombosis
1%
Rash
1%
Coronary artery disease
1%
Diplopia
1%
Eye allergy
1%
Poor dental condition
1%
Cellulitis
1%
Laceration
1%
Muscle strain
1%
Decreased appetite
1%
Headache
1%
Chronic obstructive pulmonary disease
1%
Muscle spasms
1%
Neck pain
1%
Synovitis
1%
Lethargy
1%
Hallucination
1%
Insomnia
1%
Asthma
1%
Hypertension
1%
Hot flush
1%
Fungal infection
1%
Haematoma
1%
Tinnitus
1%
Influenza like illness
1%
Flank pain
1%
White blood cells urine positive
1%
Spinal compression fracture
1%
Non-cardiac chest pain
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
3Treatment groups
Experimental Treatment
Placebo Group
Group I: AVP-786; Dose 2Experimental Treatment1 Intervention
Participants will receive AVP-786 (Dose 2) capsules administered twice a day over a 12-week period.
Group II: AVP-786; Dose 1Experimental Treatment1 Intervention
Participants will receive AVP-786 (Dose 1) capsules administered twice a day over a 12-week period.
Group III: 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
12,600 Total Patients Enrolled
Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
246 Previous Clinical Trials
166,568 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been very agitated and disruptive in your daily routine for at least 2 weeks, and your doctor has prescribed medication for it.You have been diagnosed with probable Alzheimer's Disease based on specific criteria from the National Institute on Aging-Alzheimer's Association.You have been very agitated and disruptive to your daily routine for at least 2 weeks and have been prescribed medication for it.The participant's agitation must match the definition agreed upon by a group of experts who study behavior changes in people with memory and thinking problems.You have a moderate level of agitation according to a specific scale.You have serious health conditions like cancer, uncontrolled diabetes, uncontrolled high blood pressure, or unstable heart, lung, kidney, or liver disease that could affect the study results.You have dementia that is not caused by Alzheimer's disease, like dementia from strokes, Parkinson's disease, or substance abuse.You have signs of being very restless, which are not caused by Alzheimer's disease or other mental or physical conditions.You have myasthenia gravis.You must be able to comply with study procedures.You are a caregiver who is willing and able to comply with all required study procedures
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: AVP-786; Dose 1
- Group 3: AVP-786; Dose 2
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Agitation in Dementia Patient Testimony for trial: Trial Name: NCT03393520 — Phase 3
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