← Back to Search

Other

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
Must not have
Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)
Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy [except skin basal-cell carcinoma], poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; week 12
Awards & highlights
Pivotal Trial

Summary

This trial tests a combination of two drugs taken by mouth to help calm severe agitation in people with Alzheimer's disease by balancing brain chemicals.

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My dementia is not mainly caused by Alzheimer's disease.
Select...
I do not have any major health issues that could affect the study's safety results.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score
Secondary study objectives
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
9%
Fall
6%
Diarrhoea
6%
Urinary tract infection
6%
Headache
4%
Somnolence
3%
Agitation
3%
Nausea
3%
Vomiting
3%
Contusion
3%
Dizziness
3%
Sinus bradycardia
2%
Oedema peripheral
2%
Laceration
2%
Electrocardiogram QT prolonged
2%
Osteoarthritis
2%
Dehydration
1%
Delirium
1%
Myalgia
1%
Weight increased
1%
Hot flush
1%
Blood alkaline phosphatase increased
1%
Abdominal pain
1%
Non-cardiac chest pain
1%
Epididymitis
1%
Hypokalaemia
1%
Sepsis
1%
Hip fracture
1%
Rib fracture
1%
Spinal compression fracture
1%
Lipase increased
1%
White blood cell count increased
1%
Cerebrovascular accident
1%
Hydroureter
1%
Nephrotic syndrome
1%
Leukocytosis
1%
Thrombocytopenia
1%
Anaemia
1%
Atrial fibrillation
1%
Ear pain
1%
Meniere's disease
1%
Conjunctival hyperaemia
1%
Conjunctivitis allergic
1%
Rectal haemorrhage
1%
Fatigue
1%
Asthenia
1%
Pain
1%
Upper respiratory tract infection
1%
Cellulitis
1%
Acute sinusitis
1%
Diverticulitis
1%
Gastroenteritis viral
1%
Pharyngitis
1%
Vaginal infection
1%
Skin abrasion
1%
Craniocerebral injury
1%
Hand fracture
1%
Neutrophil count increased
1%
Blood urea increased
1%
Blood glucose increased
1%
Blood lactate dehydrogenase increased
1%
Crystal urine
1%
Electrocardiogram abnormal
1%
Fungal test positive
1%
Gamma-glutamyltransferase increased
1%
Glucose urine present
1%
Haemoglobin decreased
1%
Lymphocyte count increased
1%
Decreased appetite
1%
Hyperglycaemia
1%
Hyperkalaemia
1%
Hyperlipasaemia
1%
Hypomagnesaemia
1%
Malnutrition
1%
Arthralgia
1%
Bursitis
1%
Basal cell carcinoma
1%
Lethargy
1%
Dyskinesia
1%
Metabolic encephalopathy
1%
Tremor
1%
Spontaneous penile erection
1%
Chronic obstructive pulmonary disease
1%
Pneumonia aspiration
1%
Cough
1%
Dyspnoea
1%
Dyspnoea exertional
1%
Epistaxis
1%
Rash
1%
Hypertension
1%
Back pain
1%
Fracture pain
1%
Hypertensive crisis
1%
Bundle branch block left
1%
Haemothorax
1%
Pneumothorax spontaneous
1%
Arthritis infective
1%
Orthostatic hypotension
1%
Alcohol poisoning
1%
Femoral neck fracture
1%
Electrocardiogram ST segment depression
1%
Ischaemic stroke
1%
Syncope
1%
Constipation
1%
Gastrooesophageal reflux disease
1%
Toothache
1%
Dry mouth
1%
Faecal incontinence
1%
Pneumonia
1%
Muscular weakness
1%
Balance disorder
1%
Nephrolithiasis
1%
Pollakiuria
1%
Gait disturbance
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
AVP-786-18
AVP-786-28

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for agitation in dementia, such as AVP-786, work through mechanisms like NMDA receptor antagonism and sigma-1 receptor agonism. Deudextromethorphan hydrobromide in AVP-786 modulates glutamate activity and provides neuroprotective effects, while quinidine sulfate increases its bioavailability by inhibiting CYP2D6. These actions are crucial as they help reduce excitotoxicity, neuroinflammation, and agitation, improving the quality of life for dementia patients.
Can pharmacological treatment of behavioural disturbances in elderly patients with dementia lower the burden of their family caregiver?

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
12,448 Total Patients Enrolled
Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
264 Previous Clinical Trials
169,329 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
~28 spots leftby Dec 2024