Your session is about to expire
← Back to Search
Other
AVP-786 for Agitation in Alzheimer's Disease
Phase 3
Recruiting
Research Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants with a diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working group criteria
Either out-patients or residents of an assisted-living facility or a skilled nursing home
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 64 weeks
Awards & highlights
Study Summary
This trial is for participants who have completed other similar trials. It allows people from the Phase 2 Study to be included.
Who is the study for?
This trial is for patients with Alzheimer's-related dementia who've completed certain earlier studies (15-AVP-786-301, 302, 12-AVR-131, or 17-AVP-786-305). They should be experiencing moderate to severe agitation and have a specific level of cognitive function. It's open to out-patients or those in assisted living/nursing homes but not for individuals at high risk of falls or with other serious health issues that could affect safety results.Check my eligibility
What is being tested?
The study tests the long-term safety and effectiveness of AVP-786 as a treatment for agitation in Alzheimer's disease patients. This extension includes participants from previous Phase 2 and Phase 3 trials on the same medication.See study design
What are the potential side effects?
While specific side effects are not listed here, typically treatments like AVP-786 may cause changes in mood or behavior, gastrointestinal issues, dizziness, headaches, and potentially increase the risk of falls among elderly patients.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Alzheimer's Disease based on NIA-AA criteria.
Select...
I live at home, in an assisted living, or a skilled nursing facility.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 64 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 64 weeks
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 52 in the Epworth Sleepiness Scale (ESS) Score
Change from Baseline to Week 52 in the Mini-Mental State Examination (MMSE) Score
Change from Baseline to Week 64 in the Sheehan Suicidality Tracking Scale (S-STS) Score
+6 moreSecondary outcome measures
Change from Baseline to Week 52 in the Agitation/Aggression, Irritability/Lability, and Aberrant Motor Behavior Domain Scores of the Neuropsychiatric Inventory (NPI)
Change from Baseline to Week 52 in the Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain Score
Change from Baseline to Week 52 in the Dementia Quality of Life (DEMQOL) Score
+5 moreOther outcome measures
Number of participants using concomitant medications
Side effects data
From 2019 Phase 3 trial • 387 Patients • NCT024427658%
Fall
4%
Diarrhoea
4%
Agitation
3%
Urinary tract infection
3%
Dizziness
3%
Somnolence
2%
Electrocardiogram QT prolonged
2%
Arthralgia
2%
Nasopharyngitis
2%
Upper respiratory tract infection
2%
Skin abrasion
1%
Chronic obstructive pulmonary disease
1%
Constipation
1%
Tendonitis
1%
Muscle rupture
1%
Coronary artery disease
1%
Poor dental condition
1%
Laceration
1%
Muscle strain
1%
Deep vein thrombosis
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%
Synovitis
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%
Foot fracture
1%
Malnutrition
1%
Bradycardia
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%
Hallucination
1%
Hypnopompic hallucination
1%
Asthma
1%
Haematoma
1%
Diplopia
1%
Tinnitus
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
Group I: AVP-786 (dose 3)Experimental Treatment1 Intervention
AVP-786 dose 3; capsules administered twice a day over a 52-week period
Group II: AVP-786 (dose 2)Experimental Treatment1 Intervention
AVP-786 dose 2; capsules administered twice a day over a 52-week period
Group III: AVP-786 (dose 1)Experimental Treatment1 Intervention
AVP-786 dose 1; capsules administered twice a day over a 52-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?
Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
246 Previous Clinical Trials
165,849 Total Patients Enrolled
Avanir PharmaceuticalsLead Sponsor
31 Previous Clinical Trials
12,001 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you sign up late, you must have a specific score on a test that checks your memory and thinking abilities.I have been diagnosed with Alzheimer's Disease based on NIA-AA criteria.I have been diagnosed with agitation as defined by the IPA.I do not have any major health issues that could affect the study's safety results.The doctor thinks you might be at a high risk of falling during the study.I am currently using or have used NUEDEXTA® within the last 2 weeks.If you sign up late, your Agitation score needs to be at least 4 (moderately ill) on the assessment tests at screening and baseline.I live at home, in an assisted living, or a skilled nursing facility.If you have been delaying enrolling in the study, you must have shown significant agitation at least 2 weeks before the start of the study.
Research Study Groups:
This trial has the following groups:- Group 1: AVP-786 (dose 3)
- Group 2: AVP-786 (dose 1)
- Group 3: AVP-786 (dose 2)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does AVP-786 have a high rate of adverse effects?
"AVP-786 falls into Phase 3 of clinical trials, meaning that there is some evidence of efficacy as well as data from multiple rounds of testing affirming its safety."
Answered by AI
How many subjects are included in this experiment?
"That is indeed correct. The most recent update on clinicaltrials.gov shows that this trial, which began recruiting on December 1st, 2015, is still looking for 1200 participants at 11 locations."
Answered by AI
Are enrolling any more participants for this research?
"Yes, the trial is still open for recruitment and has been since December 1st, 2015. The most recent update to the listing was on September 23rd, 2022. There are 11 sites total enrolling 1200 patients."
Answered by AI
Does this research involve persons aged 55 and older?
"This clinical trial is specifically for patients aged 50 to 90. In contrast, there are 45 other studies for people under the age of 18 and 770 for people over 65."
Answered by AI
Are there any prerequisites for joining this particular clinical trial?
"This trial is looking for 1200 individuals aged 50-90 who have a diagnosis of dementia. To be eligible, patients must have successfully completed one of the following studies: 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305. Additionally, participants must have a Mini-Mental State Examination (MMSE) score between 6 and 26 at screening and baseline, and a diagnosis of agitation that meets the International Psychogeriatric Association (IPA) provisional definition of agitation. Agitation must be clinically significant and moderate to"
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger