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

NCT01055379 | Completed Phase 4

• 2 other identifiers: 12962A2009-011144-19
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Depressive Symptoms; Parkinson's Disease

Keywords

Rasagiline; Depressive Symptoms; Cognition

Outcome Measures

Primary Outcomes (1)

• Change from baseline in BDI-IA total score

  12 weeks

Secondary Outcomes (4)

• 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

  12 weeks

• Change in quality of life using the PDQ-39 scale

  12 weeks

• Change in apathy using the Apathy Scale

  12 weeks

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

  12 weeks

Study Arms (2)

Rasagiline

EXPERIMENTAL

Drug: Rasagiline

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Rasagiline DRUG

1 mg/day for 12 weeks; orally

Also known as: Azilect

Rasagiline

Placebo DRUG

Once daily for 12 weeks; orally

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lundbeck Italia S.p.A.: lead
• Teva Branded Pharmaceutical Products R&D, Inc.: collaborator

Study Sites (12)

IT010

Cagliari, 9134, Italy

Location

IT007

Chieti, 66013, Italy

Location

IT004

Genova, 16132, Italy

Location

IT005

Lido di Camaiore, 55043, Italy

Location

IT003

Messina, 98122, Italy

Location

IT012

Milan, 20135, Italy

Location

IT001

Naples, 80131, Italy

Location

IT011

Roma, 161, Italy

Location

IT008

Rome, 133, Italy

Location

IT015

Torino, 10126, Italy

Location

IT013

Venezia, 30126, Italy

Location

IT009

Verona, 37134, Italy

Location

MeSH Terms

Conditions

Depression; Parkinson Disease

Interventions

rasagiline

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2010
• First Posted: January 25, 2010
• Study Start: March 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 31, 2021

Record last verified: 2021-08

Locations

IT (12)