NCT00696215

Brief Summary

The objective of the study is to assess the effects of rasagiline on cognitive functions in patient with Parkinson's disease. Patients on any dopaminergic medications will be assigned to receive rasagiline 1 mg or placebo over 3 months. Cognitive functions will be assessed by selected neuropsychological tests representing each cognitive domain.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2007

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

June 12, 2008

Status Verified

June 1, 2008

Enrollment Period

1 year

First QC Date

June 10, 2008

Last Update Submit

June 11, 2008

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaserasagilinecognitionMAO-B

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure will be the total cognitive score. This will be calculated by adding the four cognitive sub-scores: attention, executive function, memory and visuo-spatial function.

    30 months

Secondary Outcomes (1)

  • The four cognitive sub-scores as well as individual tests scores will be analyzed separately. The changes from baseline to the end of the study in the GDS, STAS and UPDRS part III scales will be analyzed.

    3 months

Study Arms (2)

1

PLACEBO COMPARATOR
Drug: placebo

2

ACTIVE COMPARATOR

Rasagiline

Drug: rasagiline

Interventions

placeboDRUG

Placebo 1 mg once a day

1
rasagilineDRUG

1mg

Also known as: Azilect
2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients of any age
  • Diagnosis of Idiopathic PD according to the UK Brain Bank Criteria for the clinical diagnosis of PD.
  • Patients with cognitive impairment associated with PD, defined as:
  • Subjective complaints of impaired cognitive functions such as forgetfulness, word finding difficulties or inattentiveness
  • Presence of objectively demonstrable cognitive deficits in at least 2 out of the 4 cognitive domains typically impaired in PD. These include attention, executive functions, memory and visuo-spatial functions. The performance in the following test scores must be 1.5 standard deviations below the mean normative score for age and education of the patient: Digit Span for attention, Letter Fluency test for executive function, Logical Memory Sub-scale from the Wechsler Memory Scale-Revised and Line Orientation Test for visuo-spatial function.
  • Patients with a Hoehn and Yahr stage I-III when "on"
  • Literate patients who are able to follow test instructions

You may not qualify if:

  • Diagnosis of dementia due to PD according to DSM IV criteria
  • Diagnosis of current major depressive episode according to DSM IV criteria
  • Presence of any other neurodegenerative disorder other than PD
  • Presence of any unstable or untreated systemic disorder such as diabetes, cardiac failure, renal failure
  • Use of any prohibited concomitant medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Marmara University

Istanbul, Turkey (Türkiye)

RECRUITING

Raif Cakmur

Izmir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

rasagiline

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • MURAT EMRE, PROF

    ISTANBUL FACULTY OF MEDICINE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

MURAT EMRE, PROF. DR

CONTACT

90-21-2533-8575muratemre@superonline.com

HASMET A HANAGASI, DR

CONTACT

90-21-2533-8575hasmet@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 10, 2008

First Posted

June 12, 2008

Study Start

June 1, 2007

Primary Completion

June 1, 2008

Study Completion

October 1, 2008

Last Updated

June 12, 2008

Record last verified: 2008-06

Locations

TU(2)