Rasagiline in Cognitive-impairment Related Depression: AzileCt in COgnitive-impairment Related DepressiOn (ACCORDO)

This study has been completed.
Sponsor:
Collaborator:
Teva Pharmaceutical Industries
Information provided by (Responsible Party):
Lundbeck Italia S.p.A.
ClinicalTrials.gov Identifier:
NCT01055379
First received: January 22, 2010
Last updated: July 2, 2012
Last verified: July 2012
  Purpose

The primary endpoint for this study is the clinical response after 12 weeks of treatment, defined as a change in total score from baseline depressive symptoms as measured by the Beck Depression Inventory-Amended (BDI-IA) total score.


Condition Intervention Phase
Depressive Symptoms
Parkinson's Disease
Drug: Rasagiline
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled Study to Evaluate if Rasagiline Can Improve Depressive Symptoms and Cognitive Function in Non-demented, Idiopathic Parkinson's Disease Patients: ACCORDO Study

Resource links provided by NLM:


Further study details as provided by Lundbeck Italia S.p.A.:

Primary Outcome Measures:
  • Change from baseline in BDI-IA total score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate if rasagiline compared to placebo improves cognitive function, over a treatment period of 12 weeks in idiopathic Parkinson´s Disease, using a formal neuropsychiatric cognitive test battery; quality of life (PDQ 39); apathy; ADL, motor function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in quality of life using the PDQ-39 scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in apathy using the Apathy Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in ADL and motor function using UPDRS scales part II and III, respectively [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 121
Study Start Date: March 2010
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rasagiline Drug: Rasagiline
1 mg/day for 12 weeks; orally
Other Name: Azilect
Placebo Comparator: Placebo Drug: Placebo
Once daily for 12 weeks; orally

Detailed Description:

ACCORDO is a multicentre, randomised, double-blind, and placebo-controlled study conducted in 12 Italian centres. Subjects are screened by means of the BDI-IA (cut-off 15) and randomised to treatment with rasagiline or placebo for 12 weeks.

Subjects have to be on stable treatment with dopaminergic agents at least 4 weeks before baseline, and maintained so during the course of the study.

The primary objective is to evaluate whether rasagiline compared to placebo improves depressive symptoms as evaluated by the BDI-IA total score.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatient, male or female aged >=40 and <80 years. The subject has a diagnosis of idiopathic Parkinson's Disease (PD) according to the United Kingdom Parkinson's Disease Society brain bank diagnostic criteria for PD for the clinical diagnosis of PD.
  • Depressive symptoms with a minimum severity of >=15 using the BDI-IA.
  • Hoehn and Yahr stage I-III.
  • Under stable (4 weeks prior to baseline) dopaminergic treatment without significant motor complication such as "on-off" phenomena and/or dyskinesia.
  • The subject and/or legal representative and/or impartial witness is/are able to read and understand the Subject Information Sheet.
  • The subject and/or legal representative has/have signed the Informed Consent Form (ICF) and if relevant the impartial witness has co-signed the ICF.
  • If female, must: agree not to try to become pregnant during the study (female patients of childbearing potential will take pregnancy test, using a urine stick), AND use adequate contraception (adequate contraception is defined as oral/systemic contraception, intrauterine device, diaphragm in combination with spermicidal, or condom for male partner in combination with spermicidal), OR have been menopausal for at least 24 months prior to baseline, (OR) have been surgically sterilised prior to baseline, OR have had a hysterectomy prior to baseline.

Exclusion Criteria:

A subject, who meets one or more of the following criteria at the Baseline Visit, is not eligible for inclusion in this study:

  • Motor complications such as wearing off and on-off phenomena.
  • Mini-Mental State Examination (MMSE) <26, corrected score.
  • Diagnosis of current or history of major depressive episode according to DSM-IV-TR® criteria within 1 year before recruitment into the study.
  • Presence of any other neurodegenerative disorder other than PD, based on judgement of investigator.
  • Psychotic symptoms, e.g. hallucination and delirium (determined by clinical evaluation).
  • Presence of any unstable or untreated systemic disorder such as diabetes, cardiac failure, or renal failure.
  • Use of any prohibited concomitant medication according to the timelines provided in Appendix II.
  • Patient who have undergone Deep Brain Stimulation surgery.
  • Current treatment with antidepressants or history of treatment with antidepressants less than 1 month prior to randomisation.
  • Current treatment or history of treatment less than 1 month prior to randomisation, with antipsychotics, cholinesterase inhibitors, memantine, amantadine, or anticholinergics.
  • Current treatment with selegiline or history of treatment with selegiline less than 90 days prior to randomisation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01055379

Locations
Italy
IT010
Cagliari, Italy, 9134
IT007
Chieti, Italy, 66013
IT004
Genova, Italy, 16132
IT005
Lido di Camaiore, Italy, 55043
IT003
Messina, Italy, 98122
IT012
Milano, Italy, 20135
IT001
Naples, Italy, 80131
IT011
Roma, Italy, 161
IT008
Rome, Italy, 133
IT015
Torino, Italy, 10126
IT013
Venezia, Italy, 30126
IT009
Verona, Italy, 37134
Sponsors and Collaborators
Lundbeck Italia S.p.A.
Teva Pharmaceutical Industries
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

No publications provided

Responsible Party: Lundbeck Italia S.p.A.
ClinicalTrials.gov Identifier: NCT01055379     History of Changes
Other Study ID Numbers: 12962A, 2009-011144-19
Study First Received: January 22, 2010
Last Updated: July 2, 2012
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Lundbeck Italia S.p.A.:
Rasagiline
Depressive Symptoms
Cognition

Additional relevant MeSH terms:
Parkinson Disease
Depression
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Behavioral Symptoms
Rasagiline
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014