MODERATO (TEVA TVP-1012/PM106)

Overview

Status: Recruiting
Keywords: Parkinson's Disease , Mild Cognitive Impairment , Movement Disorder
IRB Number: 00060662
Specialty: Neurology, Neurology
Sub Specialties: Movement Disorders, Parkinson's Disease

Brief Summary

The primary objective of the study is to determine whether 1 mg/day of rasagiline is more effective than placebo in improving cognitive function in patients with mild cognitive impairment (MCI) in Parkinson's disease (PD-MCI), as assessed by the Scales for Outcomes of Parkinson's Disease-Cognition (SCOPA-COG) after 24 weeks of treatment.

The secondary objectives of the study will be the following:

  1. Change in the Unified Parkinson's disease rating scale (UPDRS) motor examination sub-scale from baseline to week 24/early discontinuation.

  2. Change in the UPDRS, ADL sub-scale from baseline to week 24/early discontinuation.

  3. Change in the Montreal Cognitive Assessment (MoCA) score from baseline to week 24/early discontinuation.

  4. Change in the Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) score from baseline to week 24/early discontinuation.

The exploratory efficacy measures will be the following:

  1. Change in the Parkinson's disease questionnaire (PDQ-8) score from baseline to week 24/early discontinuation.

  2. Change in the Starkstein Apathy Scale (Starkstein AS) score from baseline to week 24/early discontinuation.

  3. Change in the Brief Smell Identification Test (B-SIT) score from baseline to week 24/early discontinuation.

The safety of rasagiline will be assessed throughout the study by evaluating AE's and vital signs measurements.  The tolerability of rasagiline will be assessed by the number (%) of patients who discontinue the study and the number (%) of patients who discontinue the study due to an AE.  

 

Principal Investigator: David Shprecher
Department: Neurology
Co Investigator: Lauren Schrock
Co Investigator: Edward Zamrini
Co Investigator: Richard King

Contact Information

Name:Tyler Hohnholt
Phone: 801-581-7978
Email: tyler.hohnholt@hsc.utah.edu

Inclusion Criteria

1. Non-demented man or woman 45 to 75 years of age with idiopathic PD based on the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria.

2. Hoehn and Yahr stage > 1 (symptoms on only 1 side of the body) with treatment and < 3 (mild to moderate bilateral disease; some postural instability; physically independent).

3. PD-MCI based on the MDS Task Force Diagnostic Criteria and the MoCA rating scale (range 21-25 inclusive).

4. Medically stable outpatient, based on the investigator's judgement.

5. The patient is on a stable dopaminergic medication regimen for > 30 days before entering the study (Screening/Baseline).

6. Women of childbearing potential (not surgically sterile or 2 years post-menopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.

7. The patient must be willing and able to give written informed consent prior to performing any study procedures.

Exclusion Criteria

1. Clinically relevant history of vascular disease (e.g. stroke).

2. History of melanoma.

3. History of deep brain stimulation (DBS).

4. Impaired hepatic function, based on the investigator's judgment.

5. Psychosis or is receiving antipsychotic treatment

6. Clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation, based on the investigator's judgment.

7. The patient has taken any investigational products within 60 days prior to the Screening/Baseline visit. 

8. The patient has taken rasagiline or any other MAOIs within 90 days prior to the Screening/Baseline visit.

9.The patient has used cognitive-enhancing medications (cholinesterase inhibitors, memantine, or over the counter (OTC) medications) within 90 days prior to the Screening/Baseline visit.

10. Other disallowed medications (taken within 30 days before the Screening/Baseline visit and during the study) include anticholinergics, mperidine, dextromethorphan, tramadol, St. John's wort, methadone, cyclobenzaprine, cocaine, ciprofloxacin, or other CYP1A2 inhibitors.

11. Uncontrolled hypertension (systolic blood pressure (BP) > 160mmHg, or diastolic BP > 100 mmHg; US National Institutes of Health Seventh Report of the Joint National Committee criteria).  Hypertensive patients whose BP is controlled with medication to systolic BP <160 mmHg and diastolic BP<100mgHg are eligible.

12. Moderate to severe dyskinesia (defined by a score of > 1 on Item 33, Part 4 of the UPDRS)

13. Experiencing "wearing off" motor fluctuations (defined by > 0 on Item 39, Part 4 of the UPDRS)

14. Impulse control disorder (ICD) based on the QUIP.

15. Moderate to severe depressive symptoms, defined as a score > 10 on the GDS-15

16. The patient is pregnant or lactating woman or is planning to become pregnant within the next 24 weeks.  (Any woman becoming pregnant during the study will be withdrawn from the study).