Remternetug for Alzheimer's Disease

(DIAN-TU-002 Trial)

Recruiting in Palo Alto (17 mi)

+34 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: Washington University School of Medicine

Must not be taking: Anticoagulants, Immunosuppressives, Chemotherapeutics, others

Disqualifiers: Neurologic, Psychiatric, Stroke, Substance use, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to test the study drug, referred to as remternetug, to determine its effectiveness for the study treatment of asymptomatic (at risk) Alzheimer disease in individuals with AD-causing mutations. This study will also investigate the effects of remternetug on biomarkers (measures of the disease including brain scans, blood and spinal fluid tests), examine safety data to identify any potential benefits or risks, and examine how well participants can tolerate remternetug. Stage 1 will determine if treatment with the study drug prevents or reverses amyloid beta (Aβ) accumulation compared with placebo in participants with dominantly inherited Alzheimer's disease (DIAD). Stage 2 will evaluate the effect of early anti-amyloid treatment on downstream biomarkers of AD in treated participants compared to external control groups.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications. However, it mentions that participants should be on stable doses of their current medications for at least 30 days before starting the trial, except for medications taken for episodic conditions. Approved treatments for Alzheimer's and other medications may be permitted.

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

Remternetug is unique because it is a new investigational drug specifically being studied for Alzheimer's disease, whereas current standard treatments like cholinesterase inhibitors and memantine focus on different mechanisms, such as enhancing neurotransmitter activity or blocking certain brain receptors.

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Eligibility Criteria

This trial is for individuals who have a genetic form of Alzheimer's disease but do not yet show symptoms. They must carry mutations that cause the disease and are at risk of developing it. Specific details about inclusion or exclusion criteria were not provided.

Inclusion Criteria

I agree not to try to become pregnant during and shortly after the study.

I have been on stable medication for over 30 days for a condition that is not excluded from the study.

Provide written informed consent, signed, and dated by the participant and study partner, or by the participant's legally authorized representative if applicable, according to local regulations for the ICF and, if applicable, country specific ICFs

Exclusion Criteria

I am able to complete all required initial visit tests and assessments.

My brain MRI does not show significant issues like major bleeding, brain damage, or aneurysms.

Any other medical condition that could be expected to progress, recur, or change to such an extent that it could bias the assessment of the clinical or mental status of the participant to a significant degree or put the participant at special risk

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage 1 Treatment

Participants receive remternetug or placebo to assess prevention or reversal of amyloid beta accumulation

104 weeks

Regular visits for imaging and biomarker assessments

Stage 2 Treatment

Evaluation of early anti-amyloid treatment effects on downstream biomarkers compared to control groups

192 weeks

Visits at Weeks 0, 48, 96, 144, and 192 for biomarker and cognitive assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Participant Groups

The study tests remternetug, which might prevent or slow down Alzheimer's in people with inherited risk. It compares remternetug to a placebo (inactive substance) using brain scans and other tests to measure its effect on the disease's biomarkers.

Group I: Stage 1: Remternetug Experimental Treatment 1 Intervention

Active Remternetug- blinded

Group II: Stage 2: Remternetug Open Label Active Control 1 Intervention

Open label will start after last dose of Stage 1

Group III: Stage 1: Matching placebo (Remternetug) Placebo Group 1 Intervention

Matching placebo

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Washington University in St. Louis Saint Louis, MO

University of Alabama in Birmingham Birmingham, AL

University of California San Diego Medical Center La Jolla, CA

Yale University School of Medicine New Haven, CT

More Trial Locations

Who Is Running the Clinical Trial?

Washington University School of Medicine Lead Sponsor

Alzheimer's Association Collaborator

National Institute on Aging (NIA) Collaborator

Eli Lilly and Company Industry Sponsor

GHR Foundation Collaborator

Private Donors Collaborator

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Clinical experience of the use of memantal in patients with moderate and severe Alzheimer's disease]. [2018] To assess the efficacy and safety of memantal, a generic formulation of memantine, in patients with moderate and severe dementia due to Alzheimer's disease (AD).

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

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.

3. England pubmed.ncbi.nlm.nih.gov

Memantine treatment in mild to moderate Alzheimer disease: a 24-week randomized, controlled trial. [2022] The objective of this study was to compare the efficacy and safety of the moderate-affinity, uncompetitive N-methyl-d-aspartate receptor antagonist, memantine, versus placebo in patients with mild to moderate Alzheimer disease (AD).

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[A comparison of the efficacy and safety of memantal and original memantine in the treatment of mild and moderate dementia in Alzheimer's disease]. [2018] To estimate the efficacy and safety of original memantine and generic medication (memantal) in patients with mild/ moderate dementia due to Alzheimer's disease (AD).

5. Netherlands pubmed.ncbi.nlm.nih.gov

Memantine treatment in patients with mild to moderate Alzheimer's disease: results of a randomised, double-blind, placebo-controlled 6-month study. [2022] Memantine is a moderate affinity, uncompetitive NMDA receptor antagonist currently approved for the treatment of moderate to severe Alzheimer's disease (AD). A 24-week, double-blind, placebo-controlled, study (Study 99679) conducted in Europe evaluated the efficacy and tolerability of 20 mg/day memantine in patients with mild to moderate AD. Patients were randomised to either memantine or placebo in a 2:1 ratio. Efficacy was primarily assessed as change from baseline in ADAS-cog and CIBIC-plus score. Of 470 patients randomised and treated (memantine, n=318; placebo, n=152), 85% and 91% completed the study. Memantine-treated patients showed statistically significant improvement relative to placebo at weeks 12 and 18, and numerical superiority at week 24 on both efficacy scales. The lack of significance at week 24 was attributed to an unexpectedly high placebo response. Memantine was well tolerated with an adverse event profile similar to placebo. The data presented support the efficacy of memantine in mild to moderate AD.