ACR16 belongs to a new class of CNS active agents called dopaminergic stabilizers. Dopaminergic stabilizers are compounds that can both enhance and counteract dopamine dependent functions in the CNS, depending on the initial level of dopaminergic activity. The stabilizing feature of such compounds is illustrated by their interaction with dopaminergic agonists.
Conditions
Interventions
Product Name: ACR16
Product Code: ACR16
Pharmaceutical Form: Capsule*
CAS Number: 346688-38-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical for
Sponsors
A. Carlsson Research AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Huntington disease diagnosed with the aid of clinical features and the presence of > 35 CAG repeats in the Huntington gene. Ambulatory and willing and able to comply with the study specific procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Second or third degree AV block or sick sinus syndrome; resting heart rate below 50 beats per minute; congestive heart failure classified as functional Class III or IV by the New York Heart Association; myocardial infarction within six months of baseline; a prolonged QTc interval at screen or pre-treatment (defined as a QTc interval of > 450 msec for males or > 470 msec for females); other clinically significant heart conditions which would negatively impact on the patient completing the study. Serum creatinine concentrations above 200 mmol/l. Any other clinically significant condition or laboratory assay abnormality that would interfere with the patient’s ability to participate in the study. Female of childbearing potential. Antichoreic medication, with exception of Risperidon, within 30 days before inclusion. If Risperidon has been taken the dose should have been kept stable for 30 days before inclusion and should remain stable throughout the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the effects of cognitive function of ACR16 treatment in Huntington disease patients. Symptomatic treatment alternatives for Huntington disease are meagre, particularly for the cognitive symptoms. Although the motor disorder of Huntington disease is severe and ultimately fatal, the most important aspects that cause suffering to patients and families are the neuropsychiatric ones, striatal abnormalities correlate with the degree of cognitive impairment, particularly with the frontal lobe deficits characteristic for the disease. The preclinical and profile of ACR16 suggests that the compound can be used to normalize states of functional dopaminergic hyperactivity without producing unwanted effects associated with antidopaminergic activity such as akinesia, rigidity and dystonia. This conception has been confirmed in a limited number of Huntington disease patients where ACR16 was shown to improve cognitive functions after 14 days of ACR16 treatment.;Secondary Objective: Secondary objectives are to assess effects on motor function, CGI, HADS and LSEQ scores. Secondary objectives will also be to assess the safety and tolerability of ACR16 in the predefined dose level. Secondary objectives relating to safety and tolerability will be frequency and severity of adverse events, drop out frequency as well as ECG morphology measured by 12-lead ECG.;Primary end point(s): The primary endpoint will be the change in the weighted total cognitive score during the study period. | — |
Countries
Denmark, Sweden
Outcome results
None listed