What side effects are associated with this type of intervention?

Common treatments for cognitive impairment, including cognitive enhancers like acetylcholinesterase inhibitors (donepezil, galantamine) and memantine, often have side effects such as gastrointestinal issues (nausea, vomiting, diarrhea), headaches, dizziness, and fatigue. More severe side effects can include cardiovascular issues and neuropsychiatric symptoms. Investigational drugs like RL-007, which are being studied for cognitive enhancement in conditions like schizophrenia, are also monitored for similar side effects, including any potential impact on blood pressure, physical health, and neurological function.

What prior FDA approvals exist?

Several drugs have been approved by the FDA for the treatment of cognitive impairment, particularly in conditions like Alzheimer's disease. Notable examples include acetylcholinesterase inhibitors such as donepezil and galantamine, which work by increasing levels of acetylcholine in the brain to improve cognitive function. Memantine, an NMDA receptor antagonist, is another FDA-approved drug that helps manage symptoms of moderate to severe Alzheimer's by regulating glutamate activity to prevent excitotoxicity. These drugs have shown varying degrees of efficacy in enhancing cognitive performance and are somewhat similar to RL-007, which is being studied for its potential cognitive enhancement effects in schizophrenia.

What other types of research exist?

Promising novel alternatives to RL-007 for cognitive enhancement in patients with cognitive impairment include: 1) Cholinesterase inhibitors like donepezil and rivastigmine, which have shown efficacy in improving cognitive function in dementia. 2) Transcranial direct current stimulation (tDCS), which is being explored for its potential to enhance cognitive performance. 3) Sarcosine, which has been suggested as a potential treatment for cognitive symptoms in schizophrenia. 4) Non-invasive neuromodulation techniques, such as transcranial magnetic stimulation (TMS), which are being investigated for their cognitive benefits.

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RL-007 for Cognitive Impairment in Schizophrenia

Verified Trial

Phase 2

Recruiting

Research Sponsored by Recognify Life Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Are you willing to avoid cannabis use during this 6 week study?

Were you diagnosed w/ Schizophrenia before March 2024?

Must not have

Are you currently taking *2 or more* different antipsychotic medications?

You have been diagnosed with Bipolar Disorder

Timeline

Screening 1 months

Treatment 6 weeks

Follow Up 2 weeks

Awards & highlights

Summary

This trial is testing a new drug, RL-007, to see if it can help people with schizophrenia think and remember better. The study will compare different doses of the drug and check for any side effects. Participants will take the drug for several weeks and complete memory and thinking tests before and after the treatment.

Who is the study for?

This trial is for adults with schizophrenia who are stable on certain antipsychotic medications, have a BMI of 40 or less, and are not expected to change housing or experience major life events during the study. They should not have been hospitalized recently for medical or psychiatric reasons, have no other major mental health diagnoses, significant brain injuries, severe substance abuse issues in the last six months, nor pose a risk of harm to themselves or others.

What is being tested?

The trial tests if RL-007 can improve cognitive abilities in people with schizophrenia. Participants will either receive RL-007 at doses of 20 mg or 40 mg, or a placebo over six weeks. Their cognitive performance before and after treatment will be compared to see if there's an improvement.

What are the potential side effects?

While specific side effects aren't listed here, safety measures like blood pressure checks, physical exams and ECGs suggest that potential side effects could include changes in heart rhythm, blood pressure variations and general discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 1 months1 visit

Treatment ~ 6 weeks3 visits

Follow Up ~ 2 weeks0 visits

Screening ~ 1 months

Treatment ~ 6 weeks

Follow Up ~2 weeks

This trial's timeline: 1 months for screening, 6 weeks for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite

Secondary study objectives

Clinical Global Impression - Severity (CGI-S)

Symbol Coding

The Attention/Vigilance domain of the MCCB

+5 more

Other study objectives

Safety measures

The Social Cognition domain of the MCCB

The Virtual Reality Functional Capacity Assessment Tool (VRFCAT)

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: RL-007 40 mgExperimental Treatment1 Intervention

oral dosing three times per day (TID)

Group II: RL-007 20 mgExperimental Treatment1 Intervention

oral dosing three times per day (TID)

Group III: PlaceboPlacebo Group1 Intervention

oral dosing three times per day (TID)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RL-007

2021

Completed Phase 2

~40

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for cognitive impairment, particularly those aimed at cognitive enhancement, often involve the modulation of neurotransmitter systems. For example, N-methyl-D-aspartate (NMDA) receptor enhancers work by improving synaptic plasticity and cognitive function through the regulation of glutamate, a key neurotransmitter involved in learning and memory. Cholinesterase inhibitors, another common treatment, increase the levels of acetylcholine in the brain, which is crucial for memory and attention. These mechanisms are important for cognitive impairment patients as they directly target the neural pathways involved in cognitive processes, potentially improving their cognitive performance and quality of life. The investigational drug RL-007, being studied for its effects on cognitive impairment associated with schizophrenia, likely operates through similar pathways to enhance cognitive function, making it a promising candidate for improving cognitive outcomes in these patients.

Effect of N-methyl-D-aspartate receptor enhancing agents on cognition in dementia: an exploratory systematic review and meta-analysis of randomized controlled trials.Observations and suggestions on antidementia drug development.Individual goal-oriented cognitive rehabilitation to improve everyday functioning for people with early-stage dementia: A multicentre randomised controlled trial (the GREAT trial).