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Mild Cognitive Impairment (MCI)

6
Pipeline Programs
16
Companies
10
Clinical Trials
3 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
0
3
0
1
1
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
1100%
+ 15 programs with unclassified modality

Competitive Landscape

15 companies ranked by most advanced pipeline stage

Angeles Therapeutics
Angeles TherapeuticsCA - Los Angeles
1 program
1
EscitalopramPhase 41 trial
Active Trials
NCT01902004Completed115Est. Jan 2019
Prevail Therapeutics
1 program
1
DonanemabPhase 3Monoclonal Antibody1 trial
Active Trials
NCT05108922Completed148Est. Sep 2023
Biocorp
BiocorpFrance - Issoire
2 programs
1
XPro1595Phase 2
transcranial electric stimulationN/A1 trial
Active Trials
NCT07092839Completed15Est. Jul 2024
INmune Bio
INmune BioFL - Boca Raton
1 program
1
XPro1595Phase 21 trial
Active Trials
NCT05321498Withdrawn0Est. Oct 2023
Neurim Pharmaceuticals
Neurim PharmaceuticalsIsrael - Tel Aviv
1 program
1
melatoninPhase 21 trial
Active Trials
NCT00544791Unknown50Est. Oct 2010
CuraSen Therapeutics
CuraSen TherapeuticsCA - San Carlos
1 program
1
CST-2032, matching placebo for CST-2032, CST-107Phase 11 trial
Active Trials
NCT05033912Withdrawn0Est. May 2022
Design Therapeutics
1 program
Insole and ankle deviceN/A
Design Pharmaceuticals
1 program
Insole and ankle deviceN/A1 trial
Active Trials
NCT07127133Not Yet Recruiting150Est. Aug 2027
Innovation Pharmaceuticals
1 program
RICORDO-DTxN/A
Mission Therapeutics
Mission TherapeuticsUK - Cambridge
1 program
RICORDO-DTxN/A
UNION therapeutics
UNION therapeuticsDenmark - Hellerup
1 program
RICORDO-DTxN/A1 trial
Active Trials
NCT06657274Recruiting60Est. Aug 2026
Soterix Medical
Soterix MedicalNJ - Woodbridge
1 program
Transcranial Alternating Current StimulationN/A1 trial
Active Trials
NCT06783283Recruiting20Est. Dec 2027
Sandoz
SandozAustria - Kundl
1 program
transcranial electric stimulationN/A
Novartis
NovartisBASEL, Switzerland
1 program
transcranial electric stimulationN/A
Colorado Therapeutics
Colorado TherapeuticsCO - Louisville
1 program
transcutaneous auricular vagus nerve stimulationN/A1 trial
Active Trials
NCT07424365Recruiting80Est. May 2028

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
Angeles TherapeuticsEscitalopram
Prevail TherapeuticsDonanemab
INmune BioXPro1595
Neurim Pharmaceuticalsmelatonin
CuraSen TherapeuticsCST-2032, matching placebo for CST-2032, CST-107
Design PharmaceuticalsInsole and ankle device
Colorado Therapeuticstranscutaneous auricular vagus nerve stimulation
Soterix MedicalTranscranial Alternating Current Stimulation
UNION therapeuticsRICORDO-DTx
Biocorptranscranial electric stimulation

Clinical Trials (10)

Total enrollment: 638 patients across 10 trials

NCT01902004Angeles TherapeuticsEscitalopram

Brain Aging and Treatment Response in Geriatric Depression

Start: Oct 2013Est. completion: Jan 2019115 patients
Phase 4Completed
NCT05108922Prevail TherapeuticsDonanemab

A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)

Start: Nov 2021Est. completion: Sep 2023148 patients
Phase 3Completed
NCT05321498INmune BioXPro1595

Study to Assess the Efficacy of XPro1595 in Patients With Mild Cognitive Impairment With Biomarkers of Inflammation

Start: Jun 2023Est. completion: Oct 20230
Phase 2Withdrawn
NCT00544791Neurim Pharmaceuticalsmelatonin

The Effect of Melatonin on Cognitive Function in Patients Diagnosed With Mild Cognitive Impairment

Start: Oct 2007Est. completion: Oct 201050 patients
Phase 2Unknown
NCT05033912CuraSen TherapeuticsCST-2032, matching placebo for CST-2032, CST-107

A Study of CST-2032 in Subjects With Cognitive Impairment

Start: Oct 2021Est. completion: May 20220
Phase 1Withdrawn
NCT07127133Design PharmaceuticalsInsole and ankle device

An Insole and Ankle Device for Monitoring Cognitive Decline in Individuals at Risk for Alzheimer's Disease and/or Alzheimer's Disease Related Dementias (AD/ADRD)

Start: Aug 2026Est. completion: Aug 2027150 patients
N/ANot Yet Recruiting
NCT07424365Colorado Therapeuticstranscutaneous auricular vagus nerve stimulation

Study to Investigate Vagus Nerve Stimulation to Augment Executive Function in Healthy and Cognitively Impaired Populations

Start: May 2025Est. completion: May 202880 patients
N/ARecruiting
NCT06783283Soterix MedicalTranscranial Alternating Current Stimulation

TACS to Engage Theta-Gamma Coupling and Enhance Working Memory in Patients With MCI (tACS-MCI)

Start: Jan 2025Est. completion: Dec 202720 patients
N/ARecruiting
NCT06657274UNION therapeuticsRICORDO-DTx

EARLY-COGN^3 - Smart Digital Solutions for EARLY Treatment of COGnitive Disability: a Neuropsychological, Neurophysiological and Neurobiological Perspective in Chronic Neurological Diseases - PNRR-MCNT2-2023-12377069

Start: Dec 2024Est. completion: Aug 202660 patients
N/ARecruiting
NCT07092839Biocorptranscranial electric stimulation

Non-invasive Deep Brain Stimulation to Enhance Motor Skill Acquisition in Individuals With Mild Cognitive Impairment

Start: Jun 2021Est. completion: Jul 202415 patients
N/ACompleted

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

1 late-stage (Phase 3) programs, potential near-term approvals
3 actively recruiting trials targeting 638 patients
16 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.