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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 up to 5 years
Awards & highlights

Summary

This trial tests AVP-786, an oral medication taken regularly, in people with Alzheimer's disease who have significant agitation. The goal is to see if it can reduce their agitation and improve their behavior.

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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%
Blood alkaline phosphatase increased
1%
Weight increased
1%
Hot flush
1%
Myalgia
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

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

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, often involve modulating neurotransmitter systems to alleviate symptoms. AVP-786 combines dextromethorphan, an NMDA receptor antagonist and sigma-1 receptor agonist, with quinidine, which inhibits the metabolism of dextromethorphan, increasing its bioavailability. This combination helps reduce excitotoxicity and modulate neurotransmitter release, which can calm agitation. Other treatments, like antipsychotics (e.g., risperidone, olanzapine) and antidepressants (e.g., citalopram), work by altering dopamine and serotonin pathways, respectively, to stabilize mood and reduce aggressive behaviors. These mechanisms are crucial as they target the neurobiological underpinnings of agitation, providing symptomatic relief and improving the quality of life for dementia patients.
AVP-786 for the treatment of agitation in dementia of the Alzheimer's type.Advancements in the treatment of agitation in Alzheimer's disease.Pseudobulbar affect in multiple sclerosis: toward the development of innovative therapeutic strategies.

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
264 Previous Clinical Trials
169,479 Total Patients Enrolled

Media Library

AVP-786 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03393520 — Phase 3
Agitation in Dementia Research Study Groups: Placebo, AVP-786; Dose 1, AVP-786; Dose 2
Agitation in Dementia Clinical Trial 2023: AVP-786 Highlights & Side Effects. Trial Name: NCT03393520 — Phase 3
AVP-786 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03393520 — Phase 3
Agitation in Dementia Patient Testimony for trial: Trial Name: NCT03393520 — Phase 3
~76 spots leftby Sep 2025
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