Behavioural and psychological symptoms of dementia
Conditions
Interventions
Not applicable.
Sponsors
Exciva GmbH
Eligibility
Age
65 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Sex: male or postmenopausal female. 2. Age: 65 to 85 years, inclusive, at screening. 3. BMI :18.0 to 35.0 kg/m2 , inclusive, at screening. 4. Status: healthy subjects. 5. Good physical and mental health based on medical history, physical examination, clinical laboratory, ECG, and vital signs, or the absence of any medical condition which, in the opinion of the Investigator, might prevent compliance with study procedures or completion. 6. Subjects must have a score of >=23 on the Mini-Mental State Exam (MMSE).
Exclusion criteria
Exclusion criteria: 1. Evidence of any active or chronic disease or condition that could interfere with, or the treatment of which could interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the Investigator (following a detailed medical history, physical examination, vital signs [systolic (SBP) and diastolic blood pressure (BP), pulse rate, body temperature], 12lead ECG, and clinical laboratory parameters [hematology, blood chemistry, and urinalysis]). Minor deviations of laboratory values from the normal range may be accepted, if judged by the Investigator as clinically irrelevant. 2. Previous participation in the current study. 3. Employee of PRA or the Sponsor. 4. History of relevant drug and/or food allergies. 5. History of alcohol abuse or drug addiction (including soft drugs like cannabis products) in the previous 2 years. 6. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, gamma hydroxybutyric acid [GHB], tricyclic antidepressants, and alcohol) at screening or at the first admission.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the pharmacokinetics (PK) of multiple doses of deramciclane in healthy elderly subjects To assess the PK of multiple doses of dextromethorphan in healthy elderly subjects To assess the PK of multiple doses of dextromethorphan and deramciclane combined in healthy elderly subjects To assess the safety and tolerability of multiple doses of deramciclane, dextromethorphan, and deramciclane combined with dextromethorphan, in healthy elderly subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicable. | — |
Countries
Netherlands
Outcome results
None listed