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A randomized, placebo-controlled trial of latrepirdine in Huntington disease
Karl Kieburtz1, Michael P McDermott, Tiffini S Voss
1Department of Neurology, University of Virginia, Charlottesville, VA 22908, USA.
Insights
Latrepirdine demonstrated good tolerability in Huntington disease (HD) patients over 90 days. The drug showed a potential benefit in improving cognitive function, as measured by the Mini-Mental State Examination (MMSE).
Area of Science:
- Neuroscience
- Clinical Pharmacology
Background:
- Huntington disease (HD) is a progressive neurodegenerative disorder.
- Current treatments for HD primarily manage symptoms, lacking disease-modifying therapies.
- Investigating novel therapeutic agents for HD is crucial.
Purpose of the Study:
- To assess the safety and tolerability of latrepirdine in individuals with mild to moderate HD.
- To explore the efficacy of latrepirdine on cognitive, behavioral, and motor symptoms in HD patients.
Main Methods:
- A double-blind, randomized, placebo-controlled, multicenter outpatient trial.
- Ninety-one participants with mild to moderate HD received either latrepirdine (20 mg three times daily) or placebo for 90 days.
- Tolerability was the primary outcome, with cognitive and motor function assessed using UHDRS, MMSE, and ADAS-cog.
Main Results:
- Latrepirdine was well tolerated, with 87% of participants completing the study compared to 82% in the placebo group.
- Adverse event rates were comparable between the latrepirdine (70%) and placebo (80%) groups.
- A statistically significant improvement in Mini-Mental State Examination (MMSE) scores was observed in the latrepirdine group (treatment effect: 0.97 points; P = .03), while no significant effects were noted on UHDRS or ADAS-cog.
Conclusions:
- Short-term administration of latrepirdine is safe and well-tolerated in patients with Huntington disease.
- Latrepirdine may offer a cognitive benefit for individuals with HD.
- Further research into latrepirdine's therapeutic potential in HD is warranted.
Objectives:
To evaluate the safety and tolerability of latrepirdine in Huntington disease (HD) and explore its effects on cognition, behavior, and motor symptoms.
Design:
Double-blind, randomized, placebo-controlled trial.
Setting:
Multicenter outpatient trial.
Participants:
Ninety-one participants with mild to moderate HD enrolled at 17 US and UK centers from July 18, 2007, through July 16, 2008.
Intervention:
Latrepirdine, 20 mg 3 times daily (n = 46), or matching placebo (n = 45) for a 90-day treatment period.
Main Outcome Measures:
The primary outcome variable was tolerability, defined as the ability to complete the study at the assigned drug dosage. Secondary outcome variables included score changes from baseline to day 90 on the Unified Huntington's Disease Rating Scale (UHDRS), the Mini-Mental State Examination (MMSE), and the Alzheimer Disease Assessment Scale-cognitive subscale (ADAS-cog).
Results:
Latrepirdine was well tolerated (87% of the patients given latrepirdine completed the study vs 82% in the placebo group), and adverse event rates were comparable in the 2 groups (70% in the latrepirdine group and 80% in the placebo group). Treatment with latrepirdine resulted in improved mean MMSE scores compared with stable performance in the placebo group (treatment effect, 0.97 points; 95% confidence interval, 0.10-1.85; P = .03). No significant treatment effects were seen on the UHDRS or the ADAS-cog.
Conclusions:
Short-term administration of latrepirdine is well tolerated in patients with HD and may have a beneficial effect on cognition. Further investigation of latrepirdine is warranted in this population with HD.
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