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Ongoing Clinical Trials for Dementia Alzheimer’s Type

This article provides detailed information about 73 ongoing clinical trials investigating treatments for Dementia Alzheimer’s type (also known as Alzheimer’s Disease, Alzheimer’s Dementia, AD). These trials are testing various medications and therapies across multiple countries in Europe, focusing on different stages of the disease from early preclinical to mild-moderate dementia. The trials involve both established medications and novel investigational drugs targeting various aspects of Alzheimer’s pathology.

Clinical trial locations

Long-Term Safety Study of ACP-204 for Adults with Alzheimer’s Disease Psychosis

This trial investigates the long-term safety and tolerability of ACP-204 in adults with Alzheimer’s disease who experience psychotic symptoms such as hallucinations or delusions. The study monitors participants for 52 weeks to assess any adverse effects and determine if the treatment is safe for extended use.

Main inclusion criteria: Participants must have completed the previous ACP-204-006 study, be between 55-85 years old, have both a study partner and designated caregiver who can attend all visits, and provide informed consent.

Main exclusion criteria: Patients without a diagnosis of Alzheimer’s Disease Psychosis, those taking medications that might interfere with the study, and those who are pregnant or breastfeeding cannot participate.

Study focus: The trial evaluates treatment-emergent adverse events, discontinuations due to adverse events, serious adverse events, and changes in cognitive function using the CGI-I-ADP score over 52 weeks.

Investigational drug: ACP-204 is administered orally in capsule form. It works by targeting neurotransmitter pathways to potentially reduce psychotic symptoms in Alzheimer’s patients.

Study of ACP-204 for Treating Psychosis in Adults with Alzheimer’s Disease

This trial evaluates the efficacy and safety of ACP-204 in treating psychosis symptoms in adults with Alzheimer’s disease. Participants receive either ACP-204 at two different doses (30 mg or 60 mg) or placebo for up to six months.

Main inclusion criteria: Participants must have early Alzheimer’s disease with confirmed amyloid pathology, show symptoms of psychosis for at least 2 months, have a CDR global score of 0.5 or 1, and have a reliable study partner.

Main exclusion criteria: Individuals not within the specified age range, those unable to provide consent, and those with other medical conditions that might interfere with the study cannot participate.

Study focus: The trial measures changes in agitation levels from baseline to Week 6 using the SAPS-H+D scale and assesses overall improvement through secondary scales.

Investigational drug: ACP-204 is administered orally in capsule form and is being studied for its potential to reduce psychotic symptoms by modulating neurotransmitter systems in the brain.

Study of trospium chloride and xanomeline tartrate (KarXT) in patients with psychosis associated with Alzheimer’s disease

This trial examines whether KarXT can reduce psychosis symptoms (hallucinations and delusions) in Alzheimer’s patients. The medication combines xanomeline and trospium chloride to target specific brain receptors while reducing peripheral side effects.

Main inclusion criteria: Participants must be 55-90 years old, have confirmed Alzheimer’s disease with biomarker evidence, display psychotic symptoms for at least 2 months, and have a designated caregiver who spends at least 8 hours per week with them.

Main exclusion criteria: History of other psychotic disorders, current use of antipsychotic medications, severe or unstable medical conditions, history of seizures, significant heart problems, substance abuse within the past 6 months, and inability to comply with study procedures.

Study focus: The primary endpoint is the change in NPI-C:H+D score from baseline. Secondary assessments include overall condition using CGI-S scale and monitoring of brain changes through MRI.

Investigational drug: KarXT is a novel combination of xanomeline (a muscarinic agonist) with trospium (a muscarinic antagonist), currently in Phase 3 trials for treating hallucinations and delusions in Alzheimer’s patients.

Study on Brain Imaging for Alzheimer’s Disease Using Florquinitau (18F) in Patients with Mild Cognitive Impairment and Early Alzheimer’s Symptoms

This study uses F18-MK6240 PET imaging to examine tau protein buildup in the brains of individuals with early Alzheimer’s disease and mild cognitive impairment, comparing findings with healthy controls.

Main inclusion criteria: Participants must have mild cognitive impairment or early Alzheimer’s disease with confirmed amyloid pathology, MMSE score between 17-30 points, and be willing to undergo multiple imaging sessions.

Main exclusion criteria: Individuals without Alzheimer’s disease diagnosis, those unable to undergo MRI or PET scans, and those with other significant medical conditions cannot participate.

Study focus: The trial examines how tau deposits correlate with brain structure and function changes, using both single timepoint and longitudinal imaging to track disease progression.

Investigational drug: F18-MK6240 is a radioactive tracer used in PET scanning to visualize tau protein aggregates in the brain, helping doctors understand disease progression.

Study on Dimethyl Fumarate for Patients with Mild Cognitive Impairment and Alzheimer’s Disease

This trial evaluates whether dimethyl fumarate, taken as an oral capsule, can reduce brain atrophy and improve cognitive function in patients with mild cognitive impairment and dementia due to Alzheimer’s disease.

Main inclusion criteria: Participants must be 55-90 years old, have MCI or mild to moderate dementia with MMSE score 17-30, CDR score 0.5-2, and have stable doses of anti-Alzheimer’s drugs for at least 3 months.

Main exclusion criteria: Patients without Alzheimer’s disease or MCI diagnosis, those outside the specified age range, and members of vulnerable populations cannot participate.

Study focus: The trial assesses cognitive function changes using various scales, monitors brain volume changes via MRI, and evaluates quality of life improvements over one year.

Investigational drug: Dimethyl fumarate at 480 mg daily is being studied for its potential neuroprotective effects through activation of the Nrf2 pathway, which helps protect brain cells from damage.

Study on Donepezil Versus Non-drug Treatment for Patients with Alzheimer’s Disease

This study compares donepezil medication to standard non-drug management for Alzheimer’s patients to determine if adding medication provides additional benefits beyond usual care.

Main inclusion criteria: Participants must have confirmed Alzheimer’s disease with specific CSF protein markers, MMSE score 10 or higher, be covered by French social security, and have adequate French language skills.

Main exclusion criteria: Individuals not diagnosed with Alzheimer’s disease, those unable to follow study procedures, and those with conditions preventing participation cannot join.

Study focus: The six-month trial evaluates cognitive function changes, quality of life improvements, and daily living activities, comparing medication treatment to non-drug interventions.

Investigational drug: Donepezil is a cholinesterase inhibitor that increases acetylcholine levels in the brain, potentially improving memory, awareness, and functional abilities.

Study on Efavirenz for Patients with Early Alzheimer’s Disease

This double-blind trial investigates whether efavirenz can influence cholesterol metabolism in the brain and potentially slow cognitive decline in early Alzheimer’s disease.

Main inclusion criteria: Participants must be 50-75 years old, have Alzheimer’s disease with confirmed CSF or amyloid PET findings, MMSE score 20 or higher, CDR global score 0.5-1.0, and have a reliable study partner.

Main exclusion criteria: Patients with other serious medical conditions, those currently in another clinical trial, those with recent surgery, severe allergies, or pregnancy/breastfeeding cannot participate.

Study focus: The study measures changes in 24-hydroxycholesterol levels and other Alzheimer’s biomarkers over the treatment period to assess efavirenz’s impact on disease progression.

Investigational drug: Efavirenz is being studied for its potential to modulate cholesterol metabolism in the brain, which may influence the progression of Alzheimer’s disease.

Study on Fasudil Hydrochloride for Memory Loss Prevention in Early Alzheimer’s Disease Patients

This 96-week study examines whether fasudil hydrochloride, a Rho-kinase inhibitor, can prevent memory loss and cognitive decline in people with early Alzheimer’s disease.

Main inclusion criteria: Participants must be over 40 years old, have early Alzheimer’s disease with confirmed amyloid pathology, CDR global score 0.5 or 1, and have a dedicated caregiver for support throughout the study.

Main exclusion criteria: Individuals without bilateral tonic-clonic seizures, those with allergies to the study medication, pregnant/breastfeeding women, those with severe kidney/liver problems, and those unable to provide informed consent cannot participate.

Study focus: The trial monitors cognitive function using the FLAME battery, conducts regular brain imaging (MRI and EEG), and assesses changes in memory and thinking abilities every six months.

Investigational drug: Fasudil hydrochloride at 40 mg three times daily is being studied for its potential to reduce abnormal brain activity and prevent memory loss in early Alzheimer’s disease.

Study on How Florquinitau (18F) Affects Brain Circuits in Early Alzheimer’s Disease Stages

This imaging study uses [18F]MK-6240 PET scans to examine how tau protein affects brain language circuits in preclinical and prodromal Alzheimer’s disease stages.

Main inclusion criteria: Participants must have mild to moderate Alzheimer’s disease, mild cognitive impairment, or be healthy controls (with or without amyloid), matched for age, education, and gender.

Main exclusion criteria: Individuals without Alzheimer’s disease or relevant cognitive conditions, those unable to undergo PET/MRI scans, and those with claustrophobia or metal implants cannot participate.

Study focus: The study evaluates tau protein distribution, brain connectivity changes, and their effects on language-related brain circuits using advanced imaging techniques.

Investigational drug: [18F]MK-6240 is a radioactive tracer administered intravenously to visualize tau protein deposits during PET scanning, helping researchers understand disease progression.

Study on ITI-1284 for Treating Agitation in Alzheimer’s Patients

This 12-week trial evaluates ITI-1284, a sublingual tablet, for treating agitation in Alzheimer’s patients, with flexible dosing starting at 10 mg and potentially increasing to 20 mg.

Main inclusion criteria: Participants must be 55+ years old, have Alzheimer’s dementia with MMSE score 6-24, show significant agitation symptoms, and have a caregiver spending about 10 hours weekly with them.

Main exclusion criteria: Patients without Alzheimer’s-related agitation, those unwilling to follow procedures, with interfering medical conditions, taking conflicting medications, or with recent participation in other trials cannot join.

Study focus: The trial measures agitation changes using CMAI and NPI-AA scales, monitors cognitive function, assesses side effects, and evaluates overall symptom improvement.

Investigational drug: ITI-1284 is taken once daily as a sublingual tablet, designed to calm agitation symptoms by influencing brain chemicals involved in mood and behavior regulation.

Summary

The 73 ongoing clinical trials for Dementia Alzheimer’s type span across multiple European countries, with notable concentrations in Spain, Germany, France, and Italy. These trials investigate a diverse range of interventions, from established treatments like donepezil and memantine to novel investigational drugs targeting various aspects of Alzheimer’s pathology.

Several key therapeutic approaches emerge from these trials. Multiple studies focus on anti-amyloid therapies (lecanemab, donanemab, bepranemab) aimed at removing protein deposits in the brain. Other trials examine anti-tau treatments (JNJ-63733657, AL002) targeting different protein accumulations associated with disease progression. Notably, there’s significant research into behavioral symptom management, particularly for agitation and psychosis, with drugs like KarXT, ITI-1284, and AVP-786.

The trials vary in scope from early Phase 1/2 studies to large-scale Phase 3 investigations, with treatment durations ranging from 12 weeks to several years. Many studies emphasize safety monitoring, particularly for ARIA (Amyloid-Related Imaging Abnormalities) and other potential side effects. The inclusion of biomarker studies and advanced imaging techniques (tau PET, amyloid PET) reflects the field’s move toward more precise disease characterization and treatment monitoring.

Most trials require participants to have confirmed Alzheimer’s pathology through biomarker testing (CSF analysis or PET scanning) and typically involve patients in early to mild stages of the disease. The consistent requirement for a study partner or caregiver across most trials underscores the practical challenges of conducting research in this population and the importance of caregiver involvement in treatment assessment.

Ongoing Clinical Trials on Dementia Alzheimer’s type

  • Study on the Safety and Effects of LY3372689 in Patients with Early Alzheimer’s Disease

    Not recruiting

    1 1
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    Investigated drugs:
    Poland

  • Study on Lecanemab and Drug Combination for Patients with Early Onset Alzheimer’s Disease Due to Genetic Mutation

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany Ireland Italy The Netherlands Spain

  • Study on the Effects of ALZ-801 in Patients Aged 50-80 with Early Alzheimer’s Disease and APOE4 Genotype

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Czechia The Netherlands

  • A study of low-dose interleukin-2 (aldesleukin) treatment in patients with early Alzheimer’s Disease

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on the Effectiveness and Safety of KarXT for Treating Psychosis in Patients with Alzheimer’s Disease

    Not recruiting

    1 1
    Investigated diseases:
    Belgium Greece Hungary Poland

  • Study on the Effects of JNJ-63733657 and Florquinitau F18 in Patients with Early Alzheimer’s Disease

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Belgium France The Netherlands Spain Sweden

  • Study on Donanemab Dosing for Adults with Early Alzheimer’s Disease

    Not recruiting

    1 1 1
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    Investigated drugs:
    Italy

  • Study on Lecanemab for Patients with Dominantly Inherited Alzheimer’s Disease to Evaluate Prevention and Progression

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

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