Table 1 Latrepirdine clinical trials for Alzheimer’s, Huntington’s disease and schizophrenia
Trial name and country | Number of participants | Patient type | Average age/MMSE at baseline | Treatment regimen | Primary end points (functional) | Outcome | Reference |
|---|---|---|---|---|---|---|---|
Russia (pilot/phase I) | 14 | Mild–moderate AD | 64–68 years | 8 weeks, 20 mg t.i.d.a | Hazegawa scale (MMSE equivalent) | Significant improvement of cognitive and self-service functions | |
Russia (phase II) | 11 sites n=183 | Mild–moderate AD | 68 years/18.7 | 6 months, N=89 on 20 mg t.i.d. N=94 on placebo | ADAS-cog CIBIC-plus | Significant improvement in cognition over placebo and baseline levels | |
CONNECTION (phase III) North and South America, Europe | 63 sites n=598 | Mild–moderate AD | 74.4 years/17.7 | 6 months N=1/3 5 mg t.i.d. N=1/3 20 mg t.i.d. N=1/3 placebo | ADAS-cog CIBIC-plus | No change in any primary or secondary outcome measures | |
CONCERT USA, UK, Europe, Australia and New Zealand | n=1050 | Mild–moderate AD on donepezil | 50 years and older/12–24 | 12 months N=1/3 5 mg t.i.d. N=1/3 20 mg t.i.d. N=1/3 placebo | ADCS-ADL ADAS-cog | No change in any primary or secondary outcome measures | |
CONTACT Europe and South America | N/A | Moderate-to-severe AD on donezepil | Terminated | 6 months 20 mg t.i.d. Placebo | N/A | N/A | |
CONSTELLATION | N/A | Moderate-to-severe AD on memantine | Terminated | N/A | N/A | N/A | |
DIMOND US and UK (phase II) | 17 sites n=91 | Mild-to-moderate HD | 52–53 years/25.1–25.6 | 90 days N=46 20 mg t.i.d. N=45 placebo | UHDRS MMSE ADAS-cog | No change in UHDRS, significant improvement in cognition (MMSE only) | |
HORIZON North America, Europe and Australia | 64 sites n=403 | Mild-to-moderate HD (>30 years of age, ⩾36 CAG polyglutamate repeat expansion) | 30 years and older | 6 months 20 mg t.i.d. Placebo | MMSE CIBIC-plus | No change in any primary or secondary outcome measures | |
Russia (phase II) | n=56 | Paranoid schizophrenia on risperidone | 35–50 years | 4–8 weeks 4–6 mg risperidone N=29 20 mg t.i.d. N=27 Placebo | PANSS, CGI-S | Improvement of negative symptoms and certain components of cognitive dysfunction |
