What were the results of the ADAGIO (Attenuation of Disease progression with Azilect Given Once-daily) study?

Updated: Jan 24, 2019
  • Author: Robert A Hauser, MD, MBA; Chief Editor: Selim R Benbadis, MD  more...
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Answer

In the large and rigorous delayed-start study called ADAGIO, patients with early Parkinson disease were randomized to rasagiline 1 mg/day for 18 months; rasagiline 2 mg/day for 18 months; placebo for 9 months, followed by rasagiline 1 mg/day for 9 months; or placebo for 9 months, followed by rasagiline 2 mg/day for 9 months. Results demonstrated that rasagiline at 1 or 2 mg/day was associated with a slower rate of worsening in the active drug groups, relative to the placebo groups. [69] Over 18 months, rasagiline 1 mg/day started early resulted in less worsening in mean total UPDRS score than when it was started late. However, for the groups that received rasagiline 2 mg/day, there was no difference at 18 months between the early-start and delayed-start groups. [69]

Based on their findings, the ADAGIO investigators concluded that early treatment with rasagiline at a dose of 1 mg/day provided benefits that were consistent with a possible disease-modifying effect, but early treatment with rasagiline at a dose of 2 mg/day did not. [69] They speculated that the effect of the 2-mg dose on symptoms may have masked any disease-modifying effects in patients with mild Parkinson disease; they also noted that it was possible that results with 1 mg/day were false positive, rather than the results with 2 mg/day being false negative. [69]

Thus, there remains interest as to whether selegiline and rasagiline improve long-term outcome for Parkinson disease patients, but this is not definitively proven, and the mechanism is unclear.


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