Logo copy here

Overview

While often more subtle than positive and negative symptoms, cognitive impairment associated with schizophrenia (CIAS) affects nearly everyone living with this disorder. Generally, CIAS persists even if the positive and negative symptoms are being managed with medication and therapy.

Currently, there are no approved drugs to treat these cognitive symptoms.

A new clinical trial for schizophrenia

Do you have a patient or know someone living with schizophrenia who might want to participate in this research? See if they could qualify by taking our short eligibility test.

Take the pre-screener Share with someone

About the investigational drug

The TALLY clinical trial aims to understand if an investigational drug could be safe and potentially effective in impacting CIAS.

This potential treatment is a positive allosteric modulator (potentiator) of the AMPA receptor that represents a mechanistically novel approach to the treatment of CIAS.

In an early study involving a small number of patients, it showed a potential to impact cognitive function in patients with CIAS.

A new clinical trial for schizophrenia

Do you have a patient or know someone living with schizophrenia who might benefit from this research? See if they could qualify by taking our short eligibility test.

Take the pre-screener Share with someone

About the TALLY clinical trial

The TALLY clinical trial is a phase 2, randomized, double-blind, multiple-dose, placebo-controlled study to evaluate the safety and potential efficacy of an investigational drug in subjects with CIAS. This clinical trial will enroll approximately 219 individuals with schizophrenia.

A new clinical trial for schizophrenia

Do you have a patient or know someone living with schizophrenia who might benefit from this research? See if they could qualify by taking our short eligibility test.

Take the pre-screener Share with someone

Key features of the TALLY clinical trial

  • All participants will use a smartphone application to keep track of their dosing schedule. They can use their own phone, or one will be provided for the duration of the study
  • All participants need a dedicated study partner – someone who knows them well, spends more than 4 hours a week with them and can attend certain visits to answer questions about any changes in the participant’s condition
  • Participants will randomly be assigned to receive either a placebo (a 1 in 3 chance) or one of two different doses of the investigational drug (a 2 in 3 chance)
  • The total length of the clinical trial is about five months
  • TALLY is a phase 2 clinical trial

We are looking for approximately 219 individuals aged 18-55 who meet the following criteria:

  • Diagnosis of schizophrenia of ≥2 years duration by DSM-5
  • Evidence of stable symptomatology ≥12 weeks (no related hospitalizations or increase in psychiatric care due to worsening of schizophrenia symptoms)
  • Have a dedicated study partner – someone who knows them well, interacts with them (in person or by telephone) at least 2 times per week, and can accompany them to certain visits

A new clinical trial for schizophrenia

Do you have a patient or know someone living with schizophrenia who might benefit from this research? See if they could qualify by taking our short eligibility test.

Take the pre-screener Share with someone

TALLY clinical trial length

The TALLY clinical trial is expected to last approximately 19 weeks for participants, including a screening phase of about 5 weeks, a dosing phase of approximately 12 weeks, and a safety follow-up phase of approximately 2 weeks.

A new clinical trial for schizophrenia

Do you have a patient or know someone living with schizophrenia who might benefit from this research? See if they could qualify by taking our short eligibility test.

Take the pre-screener Share with someone

Visits

During the clinical trial, participants will visit a trial clinic about once every two weeks. Health assessments will vary between visits but may include:

  • Physical exams
  • Activities involving thinking, learning and memory
  • Vital signs
  • Questionnaires
  • Blood samples
  • Urine samples

A new clinical trial for schizophrenia

Do you have a patient or know someone living with schizophrenia who might benefit from this research? See if they could qualify by taking our short eligibility test.

Take the pre-screener Share with someone
Biogen 225 Binney Street Cambridge, MA 02412
Privacy policy
Biogen-04403 263CS201_TALLYWebsite_v3_08Jan20
  • A
  • A
  • A
High-contrast Proceed