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Outcome Measures

Primary Outcomes (1)

Changes from baseline to endpoint (Week 6) in the Cohen-Mansfield Agitation Inventory - International Psychogeriatric Association (CMAI-IPA) score
The CMAI is used to assess the frequency of manifestations of agitated behaviors in elderly persons. It consists of 29 agitated behaviors that are further categorized into distinct agitation syndromes, also known as CMAI factors of agitation. These distinct agitation syndromes include aggressive behavior, physically nonaggressive behavior, and verbally agitated behavior. Each of the 29 items is rated on a 7-point scale of frequency (1 = never, 2 = less than once a week but still occurring, 3 = once or twice a week, 4 = several times a week, 5 = once or twice a day, 6 = several times a day, 7 = several times an hour). The ratings are based on the 2 weeks preceding assessment of the CMAI. Higher scores indicate higher frequency of agitated behaviors while lower scores indicate lower frequency of agitated behaviors The CMAI-IPA includes 19 items that were mapped to IPA agitation domains. The total score ranges from 19 to 133 with higher scores indicating more severity.
Baseline to Week 6

Secondary Outcomes (1)

Changes from baseline to endpoint (Week 6) in the Clinical Global Impression of Severity of Illness (CGI-S) score as related to symptoms of agitation
Baseline to Week 6

Other Outcomes (3)

Changes from baseline to endpoint (Week 6) in the Neuropsychiatric Inventory - Clinician (NPI-C) Caregiver Distress score for Agitation and Aggression domains
Baseline to Week 6
Changes from baseline to endpoint (Week 6) in the Neuropsychiatric Inventory - Clinician (NPI-C) Irritability/Liability Domain score
Baseline to Week 6
Changes from baseline to endpoint (Week 6) in the Neuropsychiatric Inventory - Clinician (NPI-C) Sleep Disorders Domain score
Baseline to Week 6

Study Arms (3)

EXV-802

EXPERIMENTAL

Participants will be assigned to treatment with EXV-802 capsules administered twice a day over a 6-week period.

Drug: EXV-802

Placebo

PLACEBO COMPARATOR

Participants will be assigned to treatment with placebo capsules administered twice a day over a 6-week period.

Drug: Placebo

EXV-801

EXPERIMENTAL

Participants will be assigned to treatment with EXV-801 capsules administered twice a day over a 6-week period.

Eligibility Criteria

Age55 Years - 90 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

The participant is an adult male or female between the ages of 55 to 90 years inclusively, who can move around by themselves, with a walker or a wheelchair.
A previously established diagnosis of AD dementia.

Study Sites (49)

Esperanza Clinical

Murrieta, California, 92562, United States

RECRUITING

Josephson Wallack Munshower Neurology PC

Indianapolis, Indiana, 46260, United States

RECRUITING

Precise Research Centers

Flowood, Mississippi, 39232, United States

RECRUITING

Galen Research LLC

Chesterfield, Missouri, 63005, United States

MeSH Terms

Interventions

Dextromethorphanderamciclane

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (3)

Study Arms (3)

EXV-802

Placebo

EXV-801

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (49)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (3)

Study Arms (3)

EXV-802

Placebo

EXV-801

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (49)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source records

Locations