A Study to Evaluate the Safety and Efficacy of BIIB104 in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS)
Recruiting
Biogen
Phase 2
The primary objective of the study is to evaluate the efficacy of BIIB104 in participants
with CIAS, using the Working Memory Domain of the MATRICS Consensus Cognitive Battery (MCCB).
The secondary objectives of this study are to evaluate the safety and tolerability of BIIB104
in participants with CIAS, and to evaluate the efficacy of BIIB104 in participants with CIAS
on measures of cognition, functioning, and psychiatric symptomology.
A Study to Explore Pharmacodynamic Effects of BIIB104 on Brain Circuitry in Healthy Participants
Completed
Biogen
Phase 1
The primary objective of the study is to explore the pharmacodynamic (PD) effects of BIIB104
on brain circuitry associated with emotional processing in healthy participants.
The secondary objectives of the study are to evaluate the safety and tolerability of BIIB104
in healthy participants; To further explore the PD effects of BIIB104 on brain circuitry
associated with emotional processing in healthy participants; To explore the PD effects of
BIIB104 on brain circuitry associated with working memory in healthy participants using the
N-Back; To explore the PD effects of BIIB104 on regional cerebral blood flow (CBF) in healthy
participants; To explore the PD effects of BIIB104 on brain circuitry during resting state in
healthy participants.
Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants
Completed
Biogen
Phase 1
The primary objective is to evaluate the pharmacokinetics (PK) of BIIB104 in healthy Japanese
and non-Japanese participants. The secondary objective is to evaluate the safety and
tolerability of multiple, oral doses of BIIB104 administered BID for 9 days, with an
additional dose occurring in the morning on Day 10 in healthy Japanese and non-Japanese
participants.
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