What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease include cholinesterase inhibitors (e.g., donepezil) and memantine. Cholinesterase inhibitors can cause gastrointestinal side effects such as nausea, vomiting, and diarrhea, as well as muscle cramps and fatigue. Memantine is generally well-tolerated but may cause dizziness, headache, confusion, and constipation. Anti-inflammatory agents, which are being studied for their potential benefits in Alzheimer's, can have side effects including gastrointestinal issues (e.g., ulcers, bleeding), cardiovascular risks (e.g., heart attack, stroke), and kidney damage. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Alzheimer's Disease, including cholinesterase inhibitors like donepezil, rivastigmine, and galantamine, as well as the NMDA receptor antagonist memantine. These treatments primarily focus on symptom management rather than targeting inflammation. While there is ongoing research into the use of anti-inflammatory agents for Alzheimer's, such as in the study evaluating their effect on cognition and inflammation, specific FDA approvals for anti-inflammatory treatments in Alzheimer's are not highlighted in the provided context.

What other types of research exist?

Promising novel alternatives to anti-inflammatory agents for Alzheimer's Disease patients in 2024 include monoclonal antibodies targeting amyloid beta plaques, such as aducanumab, and therapies targeting tau protein aggregation. Additionally, treatments focusing on neuroinflammation and synaptic dysfunction are under investigation and may offer new avenues for managing Alzheimer's Disease.

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Monoclonal Antibodies

Anti-Inflammatory Drugs for Mild Alzheimer's Disease

Phase 2

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A diagnosis of probable MCI due to AD or mild AD according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria

Male or female, age ≥ 45 years and ≤ 90 years at the time of signing the informed consent

Must not have

Diagnosis of vascular dementia prior to screening (e.g.., modified Hachinski Ischaemic Scale score > 6 or those who meet the NINDS AIREN criteria for vascular dementia)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 30 days post last dose

Summary

This trial is testing anti-inflammatory drugs to see if they can help people with early Alzheimer's disease who have signs of inflammation. The goal is to see if reducing inflammation can improve memory and thinking. The study will also check if these drugs are safe and well-tolerated. The trial aims to determine if these drugs can prevent Alzheimer's disease.

Who is the study for?

This trial is for men and women aged 45-90 with mild cognitive impairment or mild Alzheimer's, confirmed by specific criteria including amyloid and tau presence. Participants must have a caregiver and meet certain cognitive test score requirements. Those with other neurological conditions, major cerebrovascular disease, or using inflammation-modulating treatments are excluded.

What is being tested?

The study tests the effectiveness of Canakinumab, an anti-inflammatory agent, against a placebo in improving cognition for early Alzheimer's patients. It also assesses safety and effects on both brain and body inflammation.

What are the potential side effects?

While not specified here, anti-inflammatory agents like Canakinumab may cause side effects such as infections due to immune suppression, allergic reactions at the injection site, digestive issues, blood disorders, and potential heart risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I am between 45 and 90 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with vascular dementia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 30 days post last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 30 days post last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 30 days post last dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in cognition as measured by the Neuropsychological Test Battery (NTB) total score

Secondary study objectives

Change from baseline in function (activities of daily living) as measured by the Everyday Cognition (eCog) total score

Change from baseline in memory as measured by the total Neuropsychological Test Battery memory composite score and change from baseline in executive function as measured by the total Neuropsychological Test Battery executive function composite score

Change from baseline in microglia activation as measured by Positron-Emission Tomography-Translocator Protein 18kDa - microglia activation

+3 more

Side effects data

From 2017 Phase 3 trial • 203 Patients • NCT02059291

50%

Diarrhoea

50%

Bronchitis

50%

Conjunctivitis

50%

Gastroenteritis

50%

Drug eruption

25%

Scleritis

25%

Ear infection

25%

Rash pruritic

25%

Hyper IgD syndrome

25%

Pyoderma gangrenosum

25%

Viral tonsillitis

25%

Pancytopenia

25%

Hepatic failure

25%

Laryngitis

25%

Familial mediterranean fever

25%

Eye allergy

25%

Eye pain

25%

Aphthous ulcer

25%

Constipation

25%

Dental caries

25%

Gastritis

25%

Haemorrhoids

25%

Nausea

25%

Stomatitis

25%

Teething

25%

Vomiting

25%

Malaise

25%

Pyrexia

25%

Influenza

25%

Nasopharyngitis

25%

Rhinitis

25%

Sialoadenitis

25%

Tonsillitis bacterial

25%

Viral upper respiratory tract infection

25%

Alanine aminotransferase increased

25%

Aspartate aminotransferase increased

25%

C-reactive protein increased

25%

Neutrophil count decreased

25%

Neutrophil count increased

25%

Serum amyloid A protein increased

25%

White blood cell count increased

25%

Dehydration

25%

Hypocalcaemia

25%

Hypophosphataemia

25%

Arthralgia

25%

Back pain

25%

Pain in extremity

25%

Pyogenic granuloma

25%

Headache

25%

Somnolence

25%

Dermatitis allergic

25%

Eczema

25%

Keloid scar

25%

Pain of skin

25%

Urticaria

25%

Skin ulcer

100%

80%

60%

40%

20%

Study treatment Arm

Randomized ACZ and Placebo HIDS/MKD Patients - ACZ Events

Randomized ACZ and Placebo crFMF Patients - Placebo Events

Randomized ACZ and Placebo TRAPS Patients - ACZ Events

Randomized ACZ and Placebo crFMF Patients - ACZ Events

Randomized ACZ and Placebo HIDS/MKD Pts - No Medication Events

Non-randomized Open Label crFMF, HIDS/MKD Patients

Any ACZ crFMF Patients - ACZ Events

Randomized ACZ and Placebo crFMF Pts - No Medication Events

Non-randomized Open Label TRAPS Patients

Any ACZ crFMF Patients - Placebo Events

Randomized ACZ and Placebo TRAPS Patients - Placebo Events

Randomized ACZ and Placebo TRAPS Pts - No Medication Events

Any ACZ HIDS/MKD Patients - No Medication Events

Any ACZ HIDS/MKD Patients - ACZ Events

Randomized ACZ and Placebo HIDS/MKD Pts - Placebo Events

Any ACZ TRAPS Patients - Placebo Events

Any ACZ TRAPS Patients - ACZ Events

Any ACZ TRAPS Patients - no Medication Events

Any ACZ HIDS/MKD Patients - Placebo Events

Any ACZ crFMF Patients - No Medication Events

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CanakinumabExperimental Treatment1 Intervention

increasing doses of sub-cutaneous injections

Group II: PlaceboPlacebo Group1 Intervention

Matching placebo sub-cutaneous injections

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Canakinumab

2011

Completed Phase 3

~3090

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Alzheimer's Disease (AD) include cholinesterase inhibitors, NMDA receptor antagonists, and anti-inflammatory agents. Cholinesterase inhibitors, such as donepezil, work by preventing the breakdown of acetylcholine, a neurotransmitter important for memory and learning, thereby improving communication between nerve cells. NMDA receptor antagonists, like memantine, help regulate glutamate activity to prevent excitotoxicity, which can damage neurons. Anti-inflammatory agents aim to reduce neuroinflammation, which is believed to contribute to AD pathology by exacerbating amyloid plaque formation and tau tangles. Reducing inflammation may help slow disease progression and improve cognitive function. These treatments are crucial as they target different aspects of AD pathology, offering a multi-faceted approach to managing symptoms and potentially slowing disease progression.