Atomoxetine and Huntington's Disease
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this research study is to evaluate the effect of atomoxetine (also known as Strattera) compared to placebo (inactive substance) on daily activities such as attention and focus, thinking ability and muscle movements in subjects with early Huntington Disease (HD) and attention deficit disorder (ADD).
Full description
No medications have been investigated to improve attention and executive functions in patients with Huntington's disease, despite the evidence that these cognitive domains can be abnormal even before motor symptom onset. Because cognitive symptoms are highly associated with functional disability, treatments aimed at improving cognitive functions would be of significant benefit to patients in the early stages of the disease. Atomoxetine is the ideal choice for such a trial. It has proven efficacy in adults with attention deficit hyperactivity disorder (ADHD) and it selectively targets norepinephrine and dopamine in the prefrontal cortex rather than in subcortical areas. This selectivity is an advantage for patients with HD, because motor side effects are less likely to be facilitated than with a psychostimulant. The present study is a feasibility study in which we propose to administer either 80 milligram (mg) atomoxetine for 4 weeks or placebo to 20 patients with early HD who also complain of mild cognitive symptoms. The groups will then crossover to the other condition (atomoxetine or placebo). Participants will be assessed on measures of ADHD symptoms and a sensitive battery of neuropsychological tests. Based on the shared neural circuitry in ADHD and HD, and the demonstrated effectiveness of atomoxetine on attention in adults with ADHD, improved performance on cognitive tests of attention and executive functions and on subjects' report of ADHD symptoms are expected in the atomoxetine treatment phase. No changes in motor status are predicted during the study.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Confirmed Huntington's disease (HD) diagnosis
- Age 18 to 65
- Must have mild HD
- Must have complaints of poor attention
Exclusion criteria
- Childhood history of attention deficit hyperactivity disorder (ADHD) symptoms
- Diagnosis of schizophrenia, bipolar affective disorder, dementia, delirium or severe anxiety
- Current use of a monoamine oxidase inhibitor (MAOI) medication
- Pregnancy
- Uncontrolled hypertension
- Tachycardia
- Cardiovascular or cerebrovascular disease
- History of a loss of consciousness for greater than (or equal to) 5 minutes
- Having any neurological disorder or insult other than Huntington disease
Trial design
Primary purpose
Allocation
Interventional model
Masking
20 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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