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Compound (company) Clinicaltrials.gov identifier | Mechanism of action | Estimated enrollment | Characteristics | Status |
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TRx0237 (LMTX) (TauRx Therapeutics Ltd.) NCT01626391 | Tau aggregation inhibitor | 9 patients already taking medications for probable mild to moderate AD (2012-2013) | TRx0237 tablets 250 mg/day (given as 125 mg bid) for 4 weeks | Phase II trial (completed) |
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TRx0237 (LMTX) (TauRx Therapeutics Ltd.) NCT01689233 | Tau aggregation inhibitor | 700 patients with probable mild AD (2012–2015) | TRx0237 100 mg tablets administered twice daily | Phase III trial (active not recruiting) |
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TRx0237 (LMTX) (TauRx Therapeutics Ltd.) NCT01689246 | Tau aggregation inhibitor | 833 patients with probable mild to moderate AD (2013–2016) | TRx0237 125 mg tablets administered twice daily | Phase III trial (active not recruiting) |
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TRx0237 (LMTX) (TauRx Therapeutics Ltd.) NCT01626378 | Tau aggregation inhibitor | 220 patients with behavioral variant of FTD (2013–2016) | TRx0237 100 mg tablet administered twice daily | Phase II trial (active not recruiting) |
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TRx0237 (LMTX) (TauRx Therapeutics Ltd.) NCT02245568 | Tau aggregation inhibitor | Subjects who have completed participation in a Phase II or Phase III trial with TRx0237 continued access to therapy to evaluate the long-term safety of TRx0237 (2014–2017) | All subjects will initially be given 200 mg/day of TRx0237 administered twice daily. Thereafter, dosing is flexible (100 mg/day to 300 mg/day) | Open label Phase II trial (currently recruiting) |
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TPI-287 (University of California, San Francisco) NCT01966666 | Microtubule-stabilizing agent | 33 patients with mild to moderate AD (2013–2015) | The purpose of the study is to determine the highest dose of TPI-287 that is safe and tolerable when administered as an intravenous infusion | Phase I trial (currently recruiting) |
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AADvac1 (Axon Neuroscience SE) NCT01850238 | Active tau-based immunotherapy | 30 patients with mild to moderate AD (2013–2015) | Patients will receive 1 dose of AADvac1 per month over 3 months, for a total of 3 administrations | Phase I trial (completed) |
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AADvac1 (Axon Neuroscience SE) NCT02031198 FUNDAMANT | Active tau-based immunotherapy | This follow-up study continues to observe patients who have completed the Phase I trial of AADvac1, for another 18 months (2014–2017) | Patients who have received 6 doses in the previous trial will be given 1-2 booster doses of AADvac1 (2 if their antibody titers decline below those achieved in the previous trial). Patients who have received 3 doses in the previous trial will be given another 3 doses and then vaccinated with booster doses as above | 18-month follow-up Phase I trial (active, not recruiting) |
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AADvac1 (Axon Neuroscience SE) NCT02579252 ADAMANT
| Active tau-based immunotherapy | 185 patients with mild AD (2016–2019) | Patients will receive 6 doses of AADvac1 in 4-week intervals and then 2 individual booster doses in 6-month intervals, for a total of 8 doses | Phase II trial (currently recruiting) |
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ACI-35 (AC Immune AG)
| Active tau-based immunotherapy | Patients with mild to moderate AD (2013–2014) | This Phase I trial compared two doses of ACI-35 to investigate its safety, tolerability, and immunogenicity | Phase I trial (active, not recruiting) |
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RG7345 (RO6926496, MAb86) (Hoffmann-La Roche) NCT02281786 | Passive tau-based immunotherapy | 48 healthy subjects (January 2015–October 2015) | Single, ascending dose, intravenous administration | Phase I trial (active, not recruiting) |
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