Current Clinical Trials

Official title

A double-blind, randomized, placebo-controlled, phase 1b study to assess the safety, tolerability, and pharmacokinetics of multiple ascending doses of THN391 in early Alzheimer’s disease (AD) subjects 

Purpose of the study

To evaluate the safety of the drug THN391 in participants who have early AD with cerebral small vessel disease (cSVD). THN391 is an antibody which targets the inflammatory epitope of fibrin. cSVD is an indicator of deposition of fibrin in the brain, the target of THN391. The study will also assess the levels of THN391 which enter the bloodstream. 

Participants

Patients with a diagnosis of Mild Cognitive Impairment (MCI) or mild AD as well as cSVD, and a MMSE score in the range 20-26, who are aged 65-80. Participants must be in good general health other than AD and cSVD. 

What is involved?

Screening: consent and eligibility assessments. If passed, participants will be randomised into active drug or placebo groups (with an allocation ratio of 3:1 active:placebo or 5:2 active:placebo depending on the cohort) and enter the treatment period.

Placebo-controlled treatment: 3 intravenous (IV) administrations of THN391 or placebo over a period of 2 months with close safety monitoring throughout (including an overnight stay at our clinical trial site following the first dose). Safety monitoring and evaluations will continue for a further 4 months after receiving the third dose. 

Throughout all stages of the trial, participants will visit us regularly in Queen Square for assessments including medical and health checks, neurological examinations, brain scans, blood and urine tests, memory and thinking questionnaires, and lumbar punctures.

Official title

A randomized, placebo-controlled, parallel group, 72-week study to evaluate the efficacy and safety of VHB937 in participants with early Alzheimer’s disease (AD) followed by an extension

Purpose of the study

To assess the safety of VHB937 and its effects on cognition and function in patients with early AD. VHB937 targets TREM2 and activates microglia (the immune cells of the brain). Preclinical experimental evidence indicates that this might attenuate the disease course in AD. 

Participants

Patients with a diagnosis of Mild Cognitive Impairment (MCI) or mild AD, with an Adas-Cog14 score of 13-54 and CDR of 0.5 or 1.0, who are aged 50-85. Participants must be in good general health other than AD. 

What is involved?

Screening: consent and eligibility assessments. If passed, participants will be randomised into active drug or placebo groups and enter the treatment period.

Placebo-controlled treatment: intravenous (IV) administrations of VHB937 or placebo every 4 weeks over a period of 18 months, with safety monitoring and efficacy assessments throughout. 

Open-label extension: at the discretion of both the participant and the Investigator, participants may enter the Extension period and continue receiving VHB937 (no placebo group) every 4 weeks, along with continued monitoring. 

Throughout all stages of the trial, participants will visit us regularly in Queen Square for assessments including medical and health checks, neurological examinations, brain scans, blood and urine tests, memory and thinking questionnaires, and optional lumbar punctures.

Official title

A phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group efficacy and safety study of Trontinemab in participants with early symptomatic Alzheimer’s disease (AD) (mild cognitive impairment [MCI] to mild dementia due to AD)

Purpose of the study

Trontinemab (RO7126209) is an anti-amyloid antibody with enhanced blood-brain barrier crossing. This study aims to assess how safe and effective Trontinemab is in slowing clinical progression in participants with a diagnosis of early AD. 

Participants

Patients with a diagnosis of MCI or mild dementia due to AD, with a MMSE score of 22-30, who are between 50 and 90 years of age. Participants must be in good general health, other than AD

What is involved?

Screening: consent and eligibility assessments. If passed, participants will be randomised into drug or placebo groups (with an allocation ratio of 1:1) and enter the treatment period.

Placebo-controlled treatment: In the induction phase, participants will receive 7 doses of drug or placebo once every 4 weeks by intravenous (IV) infusion. Then, during the maintenance phase, participants will receive drug or placebo once every 12 weeks, for a year. 

Open-label extension: participants who consent and are eligible may choose to participate in the OLE study.

Throughout all stages of the trial, participants will visit us regularly in Queen Square for assessments including medical and health checks, neurological examinations, brain scans, blood and urine tests, memory and thinking questionnaires, and optional lumbar punctures.

Official title
A phase 1 study to evaluate the safety and tolerability of ALN-APP in patients with early onset Alzheimer’s disease (AD)

Purpose of the study
To evaluate the safety (side effects) of a drug called ALN- APP. This drug may have the potential to slow disease progression by reducing production of amyloid protein, which builds up in the brains of people with AD.

Participants
Patients with a diagnosis of early onset AD (onset <65 years), with a MMSE score of 21+, who are over the age of 18. Participants must be in good general health, other than AD.

What is involved?
In Part A of the study, participants will make a total of approx. 18 visits over a period of just over a year. Each visit will take approx. 3 to 6 hours depending on the procedures completed at each visit. An overnight stay may also be required. If a participant passes screening, a single dose of ALN-APP or placebo is administered, and they are closely monitored for several months afterwards. Assessments include medical and neurological examinations, memory and thinking questionnaires, blood and urine tests, brain scans (MRI and PET), and a lumbar puncture.

Part B will be a multi-dose open-label period including patients previously enrolled in Part A, as well as new participants. This will involve multiple administrations of ALN-APP (all patients will receive the active drug and there will be no placebo). The estimated duration of Part B for each participant is up to 2 years, including a 12 month dosing period (7 separate visits) and 6-12 month follow-up period (at least 2-3 visits).

Official title

A phase 1b/2a, randomized, double-blind, placebo-controlled, multiple-ascending dose, parallel-group study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7126209 following intravenous infusion in patients with prodromal or mild to moderate Alzheimer’s disease (AD)

Purpose of the study

To assess the safety and side effects of Trontinemab (RO7126209), an anti-amyloid antibody with enhanced blood-brain barrier crossing, in patients with prodromal or mild to moderate AD.

Participants

Patients with a diagnosis of Mild Cognitive Impairment (MCI) due to AD, or mild to moderate AD, with a MMSE score of 18-28, who are between 50 and 85 years of age. Participants must be in good general health, other than AD.

What is involved?

Screening: consent and eligibility assessments. If passed, participants will be randomised into drug or placebo groups (with an allocation ratio of 4:1) and enter the treatment period.

Placebo-controlled treatment: Intravenous (IV) administration of gradually increasing doses of drug (or placebo) with close safety monitoring at each dose escalation, followed by continued treatment at the determined optimum dosing regimens (or placebo). There will be a treatment period of 28 weeks, followed by a period of safety monitoring, then another treatment period of 24 weeks followed by further safety monitoring.

Open-label extension: Eligible participants may be offered continued treatment with the active drug (no placebo group) and safety monitoring for approx. 2 years.

Throughout all stages of the trial, participants will visit us regularly in Queen Square for assessments including medical and health checks, neurological examinations, brain scans, blood and urine tests, memory and thinking questionnaires, and lumbar punctures.

Official title

A single- and multiple-ascending dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of LY3954068 in patients with early symptomatic Alzheimer’s disease (AD)

Purpose of the study

A phase I, randomised, double-blind, placebo-controlled study to evaluate the safety of LY3954068 in participants with early symptomatic Alzheimer's Disease. The study will also investigate how much LY3954068 gets into the bloodstream and will test the effects of LY3954068 on CSF tau protein and other markers of AD.

Participants

Patients with a diagnosis of early AD, with a MMSE score of 18-30, who are between 50 and 85 years of age. Participants must be in good general health, other than AD.

What is involved?

The study will be comprised of two parts, A and B. Part B is optional. Each enrolled participant in Part A will be randomly assigned to receive a single dose of LY3954068 or placebo (no active drug) into the spinal fluid. If conducted, each participant in Part B would receive 2 doses of either LY3954068 or placebo, which is salty water, administered into the spinal fluid. Participants will receive active drug or placebo in a 3:1 ratio. After screening, participants will be required to stay at the research site for 2-3 nights. The study will last up to approx 45 weeks (10 months) for Part A, and, if conducted, 73 weeks (17 months) for Part B, including the screening period. There may also be an optional Open Label Extension study for this trial.

Participants will visit us in Queen Square, London, for drug/placebo administration, and also for assessments including medical and neurological examinations, memory and thinking questionnaires, blood and urine tests, brain scans, and lumbar punctures. 

A phase 2 study assessing safety and efficacy of anti-tau drug BIIB080 in patients with Mild Cognitive Impairment (MCI) and mild AD. Biogen are investigating if reducing tau production will slow down the progression of cognitive dysfunction.

A phase 2b trial investigating the safety and efficacy of miridesap, a drug which reduces a protein called Serum Amyloid P Component, in mild AD.

A phase 2/3 trial evaluating biomarker, cognitive, and clinical endpoints following open-label lecanemab administration alongside another potential disease-modifying therapy, E2814 in patients with Dominantly Inherited Alzheimer’s Disease (DIAD).

An open label study to treat DIAD mutation carrierswho participated in the DIAN-TU-001 gantenerumab OLE (open label extension) period, with lecanemab for a minimum of 5 years.

A phase 2 study to assess the efficacy and safety of GSK4527226 in participants with early AD (including Mild Cognitive Impairment (MCI) and mild dementia due to AD). GSK4527226 is an antibody which blocks sortilin and increases PGRN levels which may reduce the rate of neuronal loss and clinical decline.

A phase I study investigating the safety of a new drug, IBC-Ab002, in patients with early AD. IBC-Ab002 is an antibody which may help suppress age-related immune system decline by blocking certain immune system pathways that cause age-related impairment, slowing progression of AD.

A Phase 3 study evaluating the safety and efficacy of donanemab (LY3002813) in participants with early symptomatic AD (prodromal AD and mild dementia due to AD) with the presence of brain tau pathology. This study will assess whether removal of amyloid plaques in the brain can slow progression of disease as assessed by clinical outcomes for cognition and function, and by imaging biomarker measures of disease pathology and neurodegeneration.