Dementia in Parkinson's disease MedDRA version: 20.0 Level: LLT Classification code 10012284 Term: Dementia due to Parkinson's disease System Organ Class: 100000014717
Conditions
Interventions
Product Name: IRL752
Pharmaceutical Form: Capsule
INN or Proposed INN: IRL752
CAS Number: 1227638-29-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceu
Sponsors
Integrative Research Laboratories AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female 55-85 years of age. 2. Female patients must be of non-childbearing potential (defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or post-menopausal females defined as 12 months of amenorrhoea [in questionable cases a blood sample with simultaneous follicle stimulation hormone (FSH) 25-140 IE/L and estradiaol =65 years) yes F.1.3.1 Number of subjects for this age range 36
Exclusion criteria
Exclusion criteria: 1. An advanced, severe, or unstable disease of any type that may interfere with the primary and secondary variable evaluations. 2. A score of 5 (wheelchair bound or bedridden) in the "on"-state on the Modified Hoehn and Yahr Staging (UPDRS Part 5). 3. A current diagnosis of any primary neurodegenerative disorder other than idiopathic PD. 4. A current diagnosis of any treatable dementia (hypothyroidism, syphilis, vitamin B12 or folate deficiency) that is verified by the investigator to be the cause of dementia. 5. A current diagnosis of probably vascular dementia according to the National Institute of Neurological Disorders and Stroke and the Association International pour la Recherche et l'Enseignement en Neurosciences (NINDS-AIREN) criteria. 6. A current diagnosis of a major depressive episode according to DSM-IV criteria. 7. A history of stereotaxic brain surgery for PD. 8. Any history of a clinically relevant heart condition, including prolonged QTc (>450 ms), clinically relevant cardiac arrhythmias, any repolarisation deficits or any other clinically significant abnormal ECG as judged by the Investigator. 9. Severe or ongoing unstable medical condition including a history of poorly controlled diabetes; obesity associated with metabolic syndrome; uncontrolled hypertension; cerebrovascular disease, or any form of clinically significant cardiac disease; symptomatic orthostatic hypotension; hepatic disease; renal failure, history of abnormal renal function; or seizures. 10. Creatinine clearance <45 ml/min (calculated according to the Cockcroft-Gault formula). 11. History of severe allergy/hypersensitivity or severe on-going allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to IRL752. 12. Treatment with Warfarin within three (3) months before study treatment. 13. Administration of another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment with less than three months between administration of last dose and first dose of IMP in this study. 14. Current or history of alcohol abuse and/or use of drugs of abuse. 15. Any planned major surgery within the duration of the study. 16. Any other condition or symptoms preventing the patient from entering the study, according to the Investigator’s judgement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the safety and tolerability of IRL752 after repeated dosing in patients with Parkinson's Disease Dementia (PDD).;Secondary Objective: 1. Evaluate the effects of IRL752 on symptoms of Parkinson's disease (PD) assessed with UPDRS part 1-4, as compared to placebo. 2. Evaluate the effects of IRL752 on postural control and walking speed assessed with TUG test, as compared to placebo. 3. Evaluate the effects of IRL752 on freezing of gait assessed with the FOGQ, as compared to placebo. 4. Evaluate the effects of IRL752 on cognitive functions assessed with the CANTAB, as compared to placebo. 5. Evaluate the effects of IRL752 on neuropsychiatric symptoms assessed with NPI-12, as compared to placebo. 6. Evaluate the effects of IRL752 on global function assessed with CIBIC-Plus, as compared to placebo. 7. Evaluate the effects of IRL752 on EEG pattern changes as compared to placebo. 8. Examine the exposure of IRL752 in patients with PDD.;Primary end point(s): The primary evaluation parameters are: Frequency, seriousness and intensity of AEs Physical examination ECG recordings Vital signs (blood pressure and pulse) Safety laboratory measurements;Timepoint(s) of evaluation of this end point: Frequency, seriousness and intensity of AEs – at visit 2-8 and Follow-up. Physical examination – at visit 8 and Follow-up. ECG recordings – at visit 6, 7 and Follow-up. Vital signs (blood pressure and pulse) – at visit 6,8 and Follow-up. Safety laboratory measurements – at visit 8 and Follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary evaluation parameters are: Change in UPDRS Part 1-4 scores from baseline to end of treatment. Change in TUG test from baseline to end of treatment. Change in FOGQ score from baseline to end of treatment. Change in CANTAB performance from baseline to end of treatment, including: - Motor Screening Task - Reaction time - Spatial Working Memory Task - One Touch Stockings of Cambridge Change in NPI-12 scores from baseline (screening) to end of treatment. CIBIC-Plus score at end of treatment. Change in resting state EEG pattern from baseline to end of treatment. Plasma concentrations of IRL752.;Timepoint(s) of evaluation of this end point: Change in UPDRS Part 1-4 scores – at visit 7. Change in TUG test – at visit 7. Change in FOGQ score – at visit 7. Change in CANTAB performance – at visit 7. Change in NPI-12 scores – at visit 8. CIBIC-Plus score – at visit 8. Change in resting state EEG pattern – at visit 7. Plasma concentrations of IRL752 – at visit 2, 6 and 7. | — |
Countries
Finland, Sweden
Contacts
Public ContactCRST Oy
Clinical Research Services Turku CRST Oy
Outcome results
None listed