What side effects are associated with this type of intervention?

Common treatments for Mild Cognitive Impairment (MCI) include cholinesterase inhibitors and NMDA receptor modulators like memantine. Cholinesterase inhibitors can cause gastrointestinal side effects such as nausea, vomiting, and diarrhea, as well as muscle cramps and fatigue. Memantine, an NMDA receptor modulator, is generally well-tolerated but can lead to dizziness, headache, confusion, and, less commonly, hallucinations and worsened neuropsychiatric symptoms. These side effects should be discussed with a healthcare provider to tailor the treatment plan to the patient's needs and tolerance.

What prior FDA approvals exist?

The FDA has approved several drugs for cognitive impairment and dementia, though specific approvals for Mild Cognitive Impairment (MCI) are limited. Memantine, an NMDA receptor antagonist, is approved for moderate to severe Alzheimer's disease and has shown some benefits in cognitive function. Other treatments include acetylcholinesterase inhibitors like donepezil and galantamine, which are used for Alzheimer's disease but not specifically for MCI. Research continues into NMDA receptor modulators like SAGE-718, which aim to improve cognitive performance in conditions like MCI and mild dementia due to Alzheimer's disease.

What other types of research exist?

Promising alternatives to SAGE-718 for Mild Cognitive Impairment patients include: 1) Cholinesterase inhibitors (e.g., donepezil, rivastigmine) which have shown efficacy in improving cognitive function in Alzheimer's Disease. 2) Memantine, an NMDA receptor antagonist, which is used for moderate to severe Alzheimer's Disease and may offer benefits for MCI. 3) Cognitive Behavioral Therapy (CBT) for insomnia, which can improve sleep and potentially cognitive function. 4) Positive allosteric modulators of α7 nicotinic-acetylcholine receptors, such as PNU-120596, which have shown potential in enhancing cognitive performance.

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SAGE-718 for Alzheimer's Disease

Phase 2

Waitlist Available

Research Sponsored by Sage Therapeutics

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Have a history, presence, and/or current evidence of brain surgery, deep brain stimulation, or any history of hospitalization due to a brain injury

Treatment with an anti-amyloid therapy (including biologics) without subsequent MRI demonstrating the absence of amyloid-related imaging abnormalities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the inform consent signing up to end of the study (up to approximately day 119)

Summary

This trial is testing SAGE-718, a drug that may help improve thinking and memory skills in people with Alzheimer's Disease by helping the brain function better.

Who is the study for?

This trial is for adults with mild cognitive impairment or mild dementia due to Alzheimer's Disease, who can still manage daily activities and have a specific score range on the MoCA test. They must not have other medical conditions that could explain their cognitive issues, nor should they be pregnant, breastfeeding, allergic to SAGE-718 ingredients like soy lecithin, or have certain neurological histories.

What is being tested?

The study tests the effects of SAGE-718 on cognitive performance in Alzheimer's patients compared to a placebo. Participants will either receive SAGE-718 or a matching dummy pill without active medication (placebo) to assess any differences in mental function outcomes.

What are the potential side effects?

While specific side effects are not listed here, participants may experience reactions related to the components of SAGE-718. Allergic responses could occur in those sensitive to its ingredients such as soy lecithin.

Eligibility Criteria

Exclusion Criteria

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

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I have had brain surgery, deep brain stimulation, or was hospitalized for a brain injury.

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I've had anti-amyloid therapy without a clear MRI afterwards.

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I am allergic to soy lecithin or other SAGE-718 ingredients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the inform consent signing up to end of the study (up to approximately day 119)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the inform consent signing up to end of the study (up to approximately day 119)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the inform consent signing up to end of the study (up to approximately day 119) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from Baseline in the Wechsler Adult Intelligence Scale Fourth Edition-IV (WAIS-IV) Coding Test

Secondary study objectives

Percentage of Participants With At least One or More Treatment-emergent Adverse Events (TEAEs) and by Severity

Side effects data

From 2022 Phase 2 trial • 18 Patients • NCT04476017

Large intestine polyp

Asthenia

Urinary tract infection

Skin laceration

Activated partial thromboplastin time prolonged

International normalized ratio increased

Leukocyturia

Eye contusions

Fall

100%

80%

60%

40%

20%

Study treatment Arm

Part A: SAGE-718 3 mg

Part B: SAGE-718 3 mg

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SAGE-718Experimental Treatment1 Intervention

Participants will receive 1.2mg of SAGE-718 orally once daily for the first 6 weeks Days 1 to 42 \[±2 days\], followed by 0.9 mg of SAGE-718 for the remainder of the Treatment period up to Day 84 Visit \[±7 days\].

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive placebo-matching capsule once daily orally throughout the treatment period for up to Day 84.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SAGE-718

2020

Completed Phase 2

~650

0 / 3Eligibility 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 Mild Cognitive Impairment (MCI) include cholinesterase inhibitors and NMDA receptor modulators. Cholinesterase inhibitors, such as donepezil, rivastigmine, and galantamine, work by increasing cholinergic transmission, which can help improve cognitive function and slow the progression of symptoms. NMDA receptor modulators, like SAGE-718, aim to enhance cognitive performance by modulating glutamatergic signaling, which is crucial for synaptic plasticity and memory formation. These treatments are significant for MCI patients as they address the neurotransmitter imbalances that contribute to cognitive decline, potentially improving quality of life and delaying the progression to more severe forms of dementia.

Efficacy and clinical relevance of cognition enhancers.Effect of galantamine on verbal repetition in AD: a secondary analysis of the VISTA trial.