Treatment of disinhibition syndrome in participants with Neurodegenerative Disorder.
Eligible participants for this study must have a diagnosis of Neurodegenerative Disorder and must exhibit disinhibition syndrome of sufficient severity to warrant treatment. This is a multicenter, randomized, double-blind, placebo-controlled, cross-over study consisting of two 6-week treatment periods. Approximately 12 participants will be enrolled at approximately 2 centers in the United States. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, United States
Change From Baseline in the Disinhibition Domain of the Neuropsychiatric Inventory (NPI)
Time frame: Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the Total NPI Score
Time frame: Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the NPI Total Caregiver Distress
Time frame: Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the NPI Disinhibition Domain Caregiver Distress
Time frame: Baseline; Week 1, Week 3, Week 6, Week 8, Week 9, Week 11, and Week 14
Change From Baseline for the Frontal Behavioral Inventory (FBI) Total Score
Time frame: Baseline; Week 1, Week 3, Week 6, Week 8, Week 9, Week 11, and Week 14
Change From Baseline for the FBI Disinhibition Domain Score
Time frame: Baseline; Week 1, Week 3, Week 6, Week 9, Week 11, and Week 14
Change From the First Assessment for the Modified Clinical Global Impression of Change (mCGIC) Scale
Time frame: Week 3, Week 6, Week 11, and Week 14
Change From the First Assessment for the Patient Global Impression of Change (PGIC) Scale
Time frame: Week 3, Week 6, Week 11, and Week 14
Change From Baseline for the Quality of Relationships (QoR) Scale
Time frame: Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the Quality of Life (QoL) Scale
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Time frame: Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the Interpersonal Reactivity Index (IRI)
Time frame: Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the Center for Neurologic Study-Lability Scale (CNS-LS)
Time frame: Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the Mini-Mental State Examination (MMSE)
Time frame: Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the Cornell Scale for Depression in Dementia (CSDD)
Time frame: Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the Stroop Color and Word Task
Time frame: Baseline; Week 6, Week 8, and Week 14