CT1812 for Early Alzheimer's Disease
Recruiting in Palo Alto (17 mi)
+39 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Cognition Therapeutics
Disqualifiers: Other dementias, Neurodegenerative conditions, Hepatitis, others
Prior Safety Data
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.
12345Eligibility 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.Participant Groups
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.
3Treatment groups
Active Control
Placebo Group
Group I: CT1812 200 mgActive Control1 Intervention
CT1812 at a dose of 300mg, n=180 group
Group II: CT1812 100 mgActive Control1 Intervention
CT1812 at a dose of 100 n=180 group
Group III: PlaceboPlacebo Group1 Intervention
Placebo, n=180 group
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of CaliforniaIrvine, CA
Oregon Health & Science UniversityPortland, OR
Mayo Clinic, RochesterRochester, MN
University of South FloridaTampa, FL
More Trial Locations
Loading ...
Who is running the clinical trial?
Cognition TherapeuticsLead Sponsor
Alzheimer's Clinical Trials ConsortiumCollaborator
National Institute on Aging (NIA)Collaborator
References
Effectiveness and safety of anti-tau drugs for Alzheimer's disease: Systematic review and meta-analysis. [2023]To assess the cognitive effectiveness and safety of tau-targeting drugs for Alzheimer's disease (AD) METHODS: The MEDLINE, Embase, Cochrane Library, PsycINFO, ClinicalTrials.gov, and WHO International Clinical Trials Registry Platform databases were searched from inception to 22 November 2021. A systematic review and meta-analysis of randomized controlled trials were performed RESULTS: Thirty-four randomized controlled trials comprising 5549 participants, of which fifteen (51.7%) had a low risk of bias, were included. The meta-analysis showed no differences in the cognitive subscale of the AD: Assessment Scale (ADAS-Cog) between anti-tau drugs and placebo (mean difference [MD]: -0.77, 95% CI: -1.64 to 0.10; minimal important difference 3.1-3.8 points, moderate certainty evidence). For ADAS-Cog, the results subgroup analysis suggested a statistical effect of tau posttranslational modifications on drug inhibition (MD: -0.80, 95% CI: -1.43 to -0.17), which was not seen with tau aggregation inhibitors or immunotherapy (interaction p = 0.24). A total of 11.0%, 5.2%, and 4.8% of drugs inhibiting tau aggregation, immunotherapy, and drugs targeting posttranslational modifications, respectively, had a reduced risk of dropouts due to adverse events (AEs).
Idebenone, a new drug in the treatment of cognitive impairment in patients with dementia of the Alzheimer type. [2022]Alzheimer's disease (AD) is a central nervous system disorder characterized by the presence of neurofibrillary tangles, neuritic plaques and dystrophic neurones in susceptible areas of the brain. Few options for treatment of AD symptomatology are available. We conducted a multicenter, randomized, double-blind, placebo-controlled, parallel trial consisting of a 90 day treatment period followed by a 30 day single blind placebo administration and by an optional long term period of treatment up to a year with idebenone in open fashion. Ninety two patients entered the study and nine of them dropped out before the first control. Treatment with idebenone was found effective on memory, attention, and orientation and in slowing down the natural progressive worsening of the disease. The most common side effects associated with this treatment were insomnia, gastralgia, nausea, and anxiety. However, all adverse effects were of mild intensity and did not require specific therapies.
A phase 2 randomized trial of ELND005, scyllo-inositol, in mild to moderate Alzheimer disease. [2021]This randomized, double-blind, placebo-controlled, dose-ranging phase 2 study explored safety, efficacy, and biomarker effects of ELND005 (an oral amyloid anti-aggregation agent) in mild to moderate Alzheimer disease (AD).
Pharmacologic approaches to cognitive deficits in Alzheimer's disease. [2018]This article reviews placebo-controlled studies addressing drug efficacy for the cognitive deficits of Alzheimer's disease. Efforts to compensate for the presynaptic cholinergic deficiency in Alzheimer's disease by pharmacologically inhibiting acetylcholine degradation have been successful in several clinical trials. Two cholinesterase inhibitors are available for Alzheimer's disease, and others most likely will soon be available. Cholinesterase inhibitors represent the only therapy currently approved for the treatment of Alzheimer's disease. The antioxidant drugs alpha-tocopherol (vitamin E) and selegiline have been demonstrated marginally superior to placebo for slowing functional deterioration in patients with moderately advanced Alzheimer's disease. Epidemiologic studies suggest protective effects against Alzheimer's disease from postmenopausal estrogen replacement and nonsteroidal anti-inflammatory drugs. Placebo-controlled studies prospectively evaluating the hypotheses generated by these epidemiologic studies are ongoing.
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]To gain insight into factors affecting the rate of decline in placebo-treated subjects participating in Alzheimer's disease (AD) clinical trials.