What side effects are associated with this type of intervention?

Common treatments for agitation in dementia, such as AVP-786 (dextromethorphan and quinidine), antipsychotics, and cholinesterase inhibitors, have various side effects. AVP-786 may cause dizziness, nausea, and potential cardiac issues due to quinidine. Antipsychotics like olanzapine and risperidone can lead to sedation, weight gain, and an increased risk of stroke. Cholinesterase inhibitors, such as donepezil, may cause gastrointestinal issues, muscle cramps, and insomnia. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for agitation in dementia that directly mirror the combination of dextromethorphan and quinidine as seen in AVP-786. However, dextromethorphan combined with quinidine has been approved for pseudobulbar affect, a condition characterized by sudden, uncontrollable episodes of crying or laughing, which can occur in patients with neurological conditions. This combination leverages quinidine to inhibit the metabolism of dextromethorphan, enhancing its central nervous system effects. For agitation in dementia, antipsychotics like risperidone and olanzapine have been used off-label, but they do not share the same mechanism of action as AVP-786.

What other types of research exist?

Promising alternatives to AVP-786 for treating agitation in dementia patients include: 1. Memantine: An NMDA receptor antagonist that has shown efficacy in managing neuropsychiatric symptoms in dementia. 2. Atypical antipsychotics such as risperidone and olanzapine: These have been used to manage agitation and psychosis in dementia, though they come with a risk of side effects. 3. Deutetrabenazine: A VMAT2 inhibitor with a favorable side effect profile, used for managing chorea in Huntington's disease, which may have potential for agitation in dementia. 4. Cannabidiol (CBD): Emerging evidence suggests potential benefits in managing neuropsychiatric symptoms in dementia, though more research is needed.

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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

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Fall

Diarrhoea

Urinary tract infection

Headache

Somnolence

Agitation

Nausea

Vomiting

Contusion

Dizziness

Sinus bradycardia

Oedema peripheral

Laceration

Electrocardiogram QT prolonged

Osteoarthritis

Dehydration

Delirium

Myalgia

Weight increased

Hot flush

Blood alkaline phosphatase increased

Abdominal pain

Non-cardiac chest pain

Epididymitis

Hypokalaemia

Sepsis

Hip fracture

Rib fracture

Spinal compression fracture

Lipase increased

White blood cell count increased

Cerebrovascular accident

Hydroureter

Nephrotic syndrome

Leukocytosis

Thrombocytopenia

Anaemia

Atrial fibrillation

Ear pain

Meniere's disease

Conjunctival hyperaemia

Conjunctivitis allergic

Rectal haemorrhage

Fatigue

Asthenia

Pain

Upper respiratory tract infection

Cellulitis

Acute sinusitis

Diverticulitis

Gastroenteritis viral

Pharyngitis

Vaginal infection

Skin abrasion

Craniocerebral injury

Hand fracture

Neutrophil count increased

Blood urea increased

Blood glucose increased

Blood lactate dehydrogenase increased

Crystal urine

Electrocardiogram abnormal

Fungal test positive

Gamma-glutamyltransferase increased

Glucose urine present

Haemoglobin decreased

Lymphocyte count increased

Decreased appetite

Hyperglycaemia

Hyperkalaemia

Hyperlipasaemia

Hypomagnesaemia

Malnutrition

Arthralgia

Bursitis

Basal cell carcinoma

Lethargy

Dyskinesia

Metabolic encephalopathy

Tremor

Spontaneous penile erection

Chronic obstructive pulmonary disease

Pneumonia aspiration

Cough

Dyspnoea

Dyspnoea exertional

Epistaxis

Rash

Hypertension

Back pain

Fracture pain

Hypertensive crisis

Bundle branch block left

Haemothorax

Pneumothorax spontaneous

Arthritis infective

Orthostatic hypotension

Alcohol poisoning

Femoral neck fracture

Electrocardiogram ST segment depression

Ischaemic stroke

Syncope

Constipation

Gastrooesophageal reflux disease

Toothache

Dry mouth

Faecal incontinence

Pneumonia

Muscular weakness

Balance disorder

Nephrolithiasis

Pollakiuria

Gait disturbance

100%

80%

60%

40%

20%

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

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

Do I qualify?Apply below to find out

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.