CT1812 for Early Alzheimer's Disease

Not currently recruiting at 51 trial locations

Overseen By Theresa Devins, DrPH, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cognition Therapeutics

Disqualifiers: Other dementias, Neurodegenerative conditions, Hepatitis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 72 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of a drug called CT1812 for individuals with early Alzheimer's disease. Researchers seek to determine if CT1812 improves memory and thinking skills compared to a placebo (a pill with no active medicine). The trial will compare two different doses of CT1812 to identify the best option. Individuals diagnosed with mild memory problems due to Alzheimer's and confirmed Alzheimer's markers in their brain scans may be suitable candidates for this study. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that CT1812, the treatment being tested, is generally safe for people. Studies have found that patients using CT1812 have not experienced any serious side effects. Common, mild side effects include headaches and nausea, which are manageable and not severe. The treatment remains under evaluation to confirm its safety and effectiveness, but results so far are promising. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Alzheimer's?

Most treatments for early Alzheimer's disease aim to manage symptoms rather than alter the disease's progression, often focusing on neurotransmitter levels. However, CT1812 stands out because it works by blocking a protein called sigma-2 receptor, potentially preventing toxic proteins from accumulating in the brain. This unique mechanism could slow down or even halt the disease's progression, offering hope for a more effective approach. Researchers are particularly excited because this could represent a significant shift from simply managing symptoms to addressing the underlying disease process itself.

What evidence suggests that CT1812 might be an effective treatment for early Alzheimer's disease?

Research suggests that CT1812, which participants in this trial may receive, might help people with early Alzheimer's disease. One study showed that CT1812 slowed the worsening of thinking and memory skills. Another study examined its effects on the brain and found changes in the connections between brain cells, indicating possible benefits for brain health. Overall, these early findings suggest that CT1812 could be promising for treating Alzheimer's. ^{3 5 6 7 8}

Who Is on the Research Team?

Anthony Caggiano, MD

Principal Investigator

Cognition Therapeutics

Are You a Good Fit for This Trial?

This trial is for people aged 50-85 with early Alzheimer's, confirmed by brain scans or biomarkers. They should have mild cognitive impairment (MMSE score of 20-30) and no major psychiatric disorders, significant brain abnormalities, other neurodegenerative diseases, or active hepatitis infections.

Inclusion Criteria

Neuroimaging (MRI) obtained during screening consistent with the clinical diagnosis of Alzheimer's disease, as based on central read

I have been diagnosed with early-stage Alzheimer's disease.

Amyloid PET scan of the brain or CSF biomarkers consistent with AD

Exclusion Criteria

Clinically significant abnormalities in screening laboratory tests

Clinical or laboratory findings consistent with other infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12, other laboratory values etc.)

Screening MRI of the brain indicative of significant abnormality

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 100mg or 200mg of CT1812 or placebo daily for 18 months

72 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CT1812
• Placebo

Trial Overview

The study tests the safety and effectiveness of CT1812 versus a placebo in those with early Alzheimer's. Participants are randomly assigned to receive either CT1812 or a placebo without knowing which one they're getting.

How Is the Trial Designed?

Group I: CT1812 200 mg Active Control 1 Intervention

CT1812 at a dose of 300mg, n=180 group

Group II: CT1812 100 mg Active Control 1 Intervention

CT1812 at a dose of 100 n=180 group

Group III: Placebo Placebo Group 1 Intervention

Placebo, n=180 group

Who Is Running the Clinical Trial?

Cognition Therapeutics

Lead Sponsor

Trials

12

Recruited

1,100+

Alzheimer's Clinical Trials Consortium

Collaborator

Trials

5

Recruited

2,800+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

In a phase 2 study involving 353 patients with mild to moderate Alzheimer's disease, the 250 mg dose of ELND005 showed acceptable safety but did not demonstrate significant clinical efficacy compared to placebo after 78 weeks.

While the primary efficacy outcomes were not significant, the treatment did lead to notable changes in biomarkers, such as increased scyllo-inositol levels and decreased Aβx-42 levels in cerebrospinal fluid, suggesting potential mechanisms for further investigation in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 2 randomized trial of ELND005, scyllo-inositol, in mild to moderate Alzheimer disease. Salloway, S., Sperling, R., Keren, R., et al.[2021]

A systematic review of 34 randomized controlled trials with 5549 participants found that tau-targeting drugs do not significantly improve cognitive function in Alzheimer's disease compared to placebo, indicating limited efficacy.

However, the analysis suggested that drugs inhibiting tau posttranslational modifications may be safer, showing a lower dropout rate due to adverse events, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of anti-tau drugs for Alzheimer's disease: Systematic review and meta-analysis. Zheng, X., Tang, Y., Yang, Q., et al.[2023]

In a multicenter trial involving 92 patients with Alzheimer's disease, idebenone treatment over 90 days showed effectiveness in improving memory, attention, and orientation, while also slowing disease progression.

The treatment was generally well-tolerated, with mild side effects such as insomnia and nausea, which did not require specific medical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Idebenone, a new drug in the treatment of cognitive impairment in patients with dementia of the Alzheimer type. Bergamasco, B., Scarzella, L., La Commare, P.[2022]

Cholinesterase inhibitors are currently the only approved medications for treating cognitive deficits in Alzheimer's disease, showing efficacy in clinical trials by compensating for the loss of acetylcholine.

Antioxidant drugs like alpha-tocopherol (vitamin E) and selegiline have shown marginal benefits over placebo in slowing functional decline in patients with moderately advanced Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacologic approaches to cognitive deficits in Alzheimer's disease. Peskind, ER.[2018]

In a review of 69 Alzheimer's disease clinical trials, study duration was found to be the most consistent predictor of cognitive decline in placebo-treated subjects, indicating that longer trials may lead to more observable changes.

Factors such as the number of investigational sites, frequency of evaluations, and the severity of dementia at baseline were inversely related to cognitive decline, suggesting that these elements should be carefully considered in the design of future clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study design factors and patient demographics and their effect on the decline of placebo-treated subjects in randomized clinical trials in Alzheimer's disease. Gold, M.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05531656

A Study to Evaluate the Safety and Efficacy of CT1812 ...

This is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy, safety, and tolerability of two doses of ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10809445/

A pilot study to evaluate the effect of CT1812 treatment on ...

Secondary objectives were to evaluate the effect of CT1812 on brain synaptic density using the SV2A PET ligand [11C]UCB-J and on brain metabolic ...

3.

ir.cogrx.com

ir.cogrx.com/press_releases/cognition-therapeutics-study-of-zervimesine-ct1812-in-early-alzheimers-disease-reaches-75-enrollment-target/

Cognition Therapeutics Study of Zervimesine (CT1812) in ...

Cognition Therapeutics Study of Zervimesine (CT1812) in Early Alzheimer's Disease Reaches 75% Enrollment Target. September 03, 2025 07:30 ET.

4.

alzdiscovery.org

alzdiscovery.org/uploads/cognitive_vitality_media/CT1812_(Elayta)_UPDATE_(drug_in_development).pdf

CT1812 (Elayta)

Neuroprotective Benefit: In a phase 2 trial, CT1812 treatment showed a trend for slowing of cognitive decline. A small earlier phase trial reported a trend ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03507790

NCT03507790 | A Study to Evaluate the Safety and ...

This Phase 2 study is designed to evaluate the safety of two doses of CT1812 administered once daily for 6 months in adults aged 50 to 85 who have been ...

6.

mayo.edu

mayo.edu/research/clinical-trials/cls-20557663

A Study to Evaluate the Safety and Efficacy of CT1812 ...

The START study is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy, safety, and tolerability of two ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05531656

A Study to Evaluate the Safety and Efficacy of CT1812 ...

This is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy, safety, and tolerability of two doses of ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9866790/

The Allosteric Antagonist of the Sigma-2 Receptors—Elayta ...

This scoping systematic review aimed to collate existing evidence of CT1812 for use in patients with AD and summarize the methodologies of ongoing trials.