CT1812 for Early Alzheimer's Disease

Recruiting at 46 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

540 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy, safety, and tolerability of two doses of CT1812 compared to placebo in participants diagnosed with early Alzheimer's disease.

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.

How is the drug CT1812 different from other Alzheimer's treatments?

CT1812 is unique because it targets a different mechanism in Alzheimer's disease by potentially preventing the aggregation of amyloid proteins, which are thought to contribute to the disease's progression. This approach is different from existing treatments like cholinesterase inhibitors, which focus on increasing neurotransmitter levels in the brain. ^{1 2 3 4 5}

Research Team

Anthony Caggiano, MD

Principal Investigator

Cognition Therapeutics

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of anti-tau drugs for Alzheimer's disease: Systematic review and meta-analysis. [2023]

2. Italy pubmed.ncbi.nlm.nih.gov

Idebenone, a new drug in the treatment of cognitive impairment in patients with dementia of the Alzheimer type. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A phase 2 randomized trial of ELND005, scyllo-inositol, in mild to moderate Alzheimer disease. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States 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. [2022]