Cognitive Decline in Non-demented PD

Parkinson's Disease Clinical Trial

Official title:

Cognitive Dysfunction in PD: Pathophysiology and Potential Treatments, a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01340885
• Other study ID #: PANUC - Lou
• Secondary ID: 5P50NS062684-02
• Status: Completed
• Phase: Phase 4
• Start date: January 2011
• Est. completion date: January 2013

Study information

• Verified date: June 2020
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the relationship between attention and quality of life and how rivastigmine and atomoxetine alter attention in non-demented persons with Parkinson's disease (PD).

Description:

Cognitive dysfunction can occur in early stage of Parkinson's disease (PD) and increases as PD progresses. Attention deficits in PD patients with dementia strongly predict the impairment of their daily living activities.

Previous studies have shown that atomoxetine improves PD executive dysfunction and rivastigmine improves attention deficits in PD patients with dementia without worsening the motor symptoms.

The aim of this study is to examine the effect of atomoxetine and rivastigmine on attention and quality of life in PD patients without disabling cognitive impairment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Parkinson's disease

• Respond to levodopa therapy

Exclusion Criteria:

• Dementia

• Psychiatric disorders including anxiety disorders, dissociative disorders, mood disorders, schizophrenia and related disorders, or ADD/ADHD

• Any clinically unstable disease such as cancer, HIV/AIDS, heart condition, liver disease, kidney or renal failure or others that might require hospitalization

• Evidence for another neurological disease (history of seizures, Alzheimer disease, multiple sclerosis or other movement disorders);

• Currently using any of the study drugs;

• Colorblindness

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Strattera
10-30 mg b.i.d. for 6 weeks
• Exelon
1.5-4.5 mg b.i.d. for 6 weeks

Other:
• Placebo
2-6 pills for 6 weeks

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attention Network Effects		6 weeks
Secondary	Quality of Life	PDQ-39	6 weeks
Secondary	Stroop Color Word Test		6 weeks
Secondary	Fatigue		6 weeks
Secondary	Depression		6 weeks
Secondary	Daytime Sleepiness		6 weeks