Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age55-90
SponsorExciva GmbH
About this trial
The goal of this clinical trial is to evaluate the safety and efficacy of EXV-802 and EXV-801 in treatment of agitation in participants with Alzheimer's Disease dementia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
The participant has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization
The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation.
Disqualifiers
The participant has a confirmed primary diagnosis of a dementia-related disease other than AD dementia.
The participant has symptoms of agitation that are not secondary to AD dementia
The participant has a history of uncontrolled seizures or a history of epilepsy.
The participant has a major medical illness or unstable medical condition
Trial design
Design model
Parallel
Treatments tested in this trial
EXV-802
DrugSpecified dose twice daily
Placebo
DrugSpecified dose twice daily
EXV-801
DrugSpecified dose twice daily
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: EXV-802Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Group C: EXV-801Experimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline to Week 6Secondary 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
The CGI-S is an observer-rated scale that measures illness severity. The CGI-S is a 7-point (1-7) scale (1 = normal, not at all ill; 7 = extremely ill) that assessed the severity of agitation in this study. Higher scores indicate severe agitation, while the lower scores indicate little or no agitation.
Time frame
Baseline to Week 6Other outcomes
1
Changes from baseline to endpoint (Week 6) in the Neuropsychiatric Inventory - Clinician (NPI-C) Caregiver Distress score for Agitation and Aggression domains
The NPI-C is a retrospective interview covering 14 neuropsychiatric symptom domains. The NPI-C version of the NPI scale was designed to be administered by the clinician to the participant and the caregiver. The caregiver is first asked to provide frequency, severity, and distress ratings for each individual item across the domains. Frequency is rated on a scale from 0 to 4. Severity is rated on a scale from 0 to 3. Separately, the rater interviews the patient to assess frequency (0 to 4) of each item. Clinician rating of clinical impression is a severity rating (0 to 3) based on all available clinical and interview information. For this endpoint, the caregiver distress will be analyzed for the agitation and aggression domains. Caregiver distress is rated on a scale from 0 to 5 with a total score range of 0 to 10 across the 2 domains. Higher scores indicate greater caregiver distress.
Time frame
Baseline to Week 62
Changes from baseline to endpoint (Week 6) in the Neuropsychiatric Inventory - Clinician (NPI-C) Irritability/Liability Domain score
The NPI-C is a retrospective interview covering 14 neuropsychiatric symptom domains. The NPI-C version of the NPI scale was designed to be administered by the clinician to the participant and the caregiver. The caregiver is first asked to provide frequency, severity, and distress ratings for each individual item across the domains. Frequency is rated on a scale from 0 to 4. Severity is rated on a scale from 0 to 3. Separately, the rater interviews the patient to assess frequency (0 to 4) of each item. Clinician rating of clinical impression is a severity rating (0 to 3) based on all available clinical and interview information. The score for the irritability/lability domain is the sum of clinical impression ratings of all items. There are 12 items in the irritability/lability domain. The minimum score for the irritability/lability domain is 0 and maximum score per domain is 36, with higher scores indicate greater symptom severity.
Time frame
Baseline to Week 63
Changes from baseline to endpoint (Week 6) in the Neuropsychiatric Inventory - Clinician (NPI-C) Sleep Disorders Domain score
The NPI-C is a retrospective interview covering 14 neuropsychiatric symptom domains. The NPI-C version of the NPI scale was designed to be administered by the clinician to the participant and the caregiver. The caregiver is first asked to provide frequency, severity, and distress ratings for each individual item across the domains. Frequency is rated on a scale from 0 to 4. Severity is rated on a scale from 0 to 3. Separately, the rater interviews the patient to assess frequency (0 to 4) of each item. Clinician rating of clinical impression is a severity rating (0 to 3) based on all available clinical and interview information. The score for the sleep disorders domain is the sum of clinical impression ratings of all items. There are 8 items in the sleep disorders domain. The minimum score for the sleep disorders domain is 0 and maximum score per domain is 24, with higher scores indicate greater symptom severity.
Time frame
Baseline to Week 6Sponsors and contacts
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Source ClinicalTrials.gov