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Rasagiline in Cognitive-impairment Related Depression: AzileCt in COgnitive-impairment Related DepressiOn

Information source: Lundbeck Italia S.p.A.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depressive Symptoms; Parkinson's Disease

Intervention: Rasagiline (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Lundbeck Italia S.p.A.

Official(s) and/or principal investigator(s):
Email contact via H. Lundbeck A/S, Study Director, Affiliation: LundbeckClinicalTrials@lundbeck.com

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change from baseline in BDI-IA total score

Secondary outcome:

Evaluate if rasagiline compared to placebo improves cognitive function, over a treatment period of 12 weeks in idiopathic ParkinsonĀ“s Disease, using a formal neuropsychiatric cognitive test battery; quality of life (PDQ 39); apathy; ADL, motor function

Change in quality of life using the PDQ-39 scale

Change in apathy using the Apathy Scale

Change in ADL and motor function using UPDRS scales part II and III, respectively

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

Minimum age: 40 Years. Maximum age: 80 Years. Gender(s): Both.

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-TRĀ®

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.

Locations and Contacts

IT010, Cagliari 9134, Italy

IT007, Chieti 66013, Italy

IT004, Genova 16132, Italy

IT005, Lido di Camaiore 55043, Italy

IT003, Messina 98122, Italy

IT012, Milano 20135, Italy

IT001, Naples 80131, Italy

IT011, Roma 161, Italy

IT008, Rome 133, Italy

IT015, Torino 10126, Italy

IT013, Venezia 30126, Italy

IT009, Verona 37134, Italy

Additional Information

Starting date: March 2010
Last updated: July 2, 2012

Page last updated: August 23, 2015

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