Cognitive Decline in Non-demented PD

Oregon Health & Science University (OHSU)

Status and phase: Completed; Phase 4

Conditions: Parkinson's Disease

Treatments: Drug: Exelon; Other: Placebo; Drug: Strattera

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01340885

PANUC - Lou

5P50NS062684-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

9 participants in 3 patient groups, including a placebo group

atomoxetine

Active Comparator group

Description:

Strattera 10-30 mg b.i.d.

Treatment:

Drug: Strattera

rivastigimine

Active Comparator group

Description:

Exelon 1.5-4.5 mg b.i.d.

Treatment:

Drug: Exelon

Placebo

Placebo Comparator group

Description:

sugar pill

Treatment:

Other: Placebo