Our clinical trials

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Types of trials we offer

The Imperial Memory Unit offers a wide range of different types of clinical trials. We offer trials aiming to slow down the progression of Alzheimer’s disease in people with Mild Cognitive Impairment (MCI) or Mild Alzheimer’s disease. Examples of such trials include Lecanemab and Donanemab trials. Additionally, we provide trials focused on preventing Alzheimer’s disease in individuals as young as 55 years old.

The method of administering treatments varies across different trials. The most common administration methods include oral ingestion (taking a tablet), infusion (via an intravenous (IV) drip), or injections (administered either at home or in a clinical setting).

 

Who can participate?

To participate in clinical trials offered by the Imperial Memory Unit, individuals must meet certain criteria. Clinical trials like this require the participant to attend with a study partner, who can be a family member or friend. They should also be able to undergo PET and MRI scans. Moreover, they should possess adequate vision, and hearing for memory testing. Furthermore, participants must demonstrate reliability and willingness to make themselves available for the duration of the study (usually ranging from 1-4 years).

For our preventative trials, any one between the ages of 55-85 without any memory symptoms are welcome to contact us to see if they are eligible for our current trials. You can apply for these trials here. 

For our MCI/Mild Alzheimer’s trial, you need to be between the ages 60-85 with a diagnosis of either MCI due to Alzheimer’s disease or mild Alzheimer’s disease. You can apply for these trials here.

 

What is involved in clinical trials?

Our trials tend to last between 1 to 4 years. However, some studies tend to include an “open-label” extension, beyond this. During the “open-label” period, all participants are offered the opportunity to switch to, or continue on the active drug arm, for an extended period of time. Even if the drug becomes licensed during the trial, you can continue on the trial. 

Furthermore, being involved in clinical trials mandates coming to the unit on a regular basis to receive the medication as well as scans and memory tests. The number of visits to the unit vary depending on the trial, with as few visits as once every couple of months, to monthly visit. We will always do our best to accompany these visits to the unit with your schedule and any potential holidays you may have.

You always have the right to withdraw from the study at any time, if you do not wish to continue.

  

Matching you to the right trial

To assist you in making an informed decision about which trial aligns best with your lifestyle, the Imperial Memory Unit offers a pre-screening process. During this process, you will have the opportunity to speak with a member of our team who will discuss the available trials with you and your study partner. We will also review your medical history to identify any factors that may affect your eligibility for specific trials. Additionally, we'll engage in a dialogue to determine which trial may be most suitable for you and your lifestyle. Pre-screening typically involves either a visit to our unit or a video call, during which we'll review your medical history and conduct some brief memory tests. Our aim is to ensure that you have all the information you need to make an informed decision about participating in our trials.

Once you've selected a clinical trial you're interested in participating in, you'll enter what's known as the "screening period." This phase is designed to ensure that you meet all the necessary criteria for the study. Typically spanning a couple of months, the screening period involves several visits to our unit. The number of visits required varies depending on the specific trial, but most trials entail a minimum of three visits. During these visits, you'll undergo memory and thinking tests and receive examinations by a doctor. Additional appointments may include blood tests and scans such as MRI and PET scans. Some trials may also necessitate a lumbar puncture. Our team will guide you through each step of the screening process, ensuring that you're well-informed and comfortable throughout.

After completing the screening period, you'll transition into the randomization phase. In this stage, participants are assigned to either the drug or placebo arm of the study. Treatment initiation occurs after the screening period concludes and the randomization phase begins.

 

Our clinical trials

Preventative Trials:

AHEAD

– recruitment open

Official Name : AHEAD 3-45 Study: A Placebo-Controlled, Double-Blind, Parallel-Treatment Arm, 216 Week Study to Evaluate Efficacy and Safety of Treatment With BAN2401 in Subjects With Preclinical Alzheimer’s Disease and Elevated Amyloid (A45 Trial) and in Subjects With Early Preclinical Alzheimer’s Disease and Intermediate Amyloid (A3 Trial)

Brief Summary : The AHEAD study is testing the investigational use of a drug called BAN2401 (also known as lecanemab, LEQEMBI™) in people with amyloid in the brain who do not have clinical symptoms of Alzheimer’s disease. The immune system produces proteins, called antibodies, to help eliminate specific substances from the body. BAN2401 is a specific type of antibody produced in the lab, called a monoclonal antibody. It binds to amyloid in the brain and has been shown to reduce the amount of this abnormal protein. The purpose of this research study is to see if study treatment with BAN2401 can help reduce the risk of developing AD dementia.

You can read more about the AHEAD study here. 

If you want to read more about Lecanemab and how it works, you can do so here.

GABriella

– recruiting soon

Official Name : A phase II, randomised, doube-blind, placebo-controlled, multiple dose, multi-center, parallel group study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO7269162 following daily oral administration in participants at risk for or at the prodromal stage of Alzheimer's disease.

Brief Summary : This trial is a Phase IIa study in which safety and long-term biomarker effects of RO7269162 will be evaluated in participants at risk for or at the prodromal stage of AD. RO7269162 is a gamma-secretase modulator, which is being developed for the treatment of Alzheimer’s disease (AD). Gamma-secretase modulation results in a decrease of amyloid production and potentially delays or prevents aggregation of toxic longer amyloid plaque accumulation and thereby reduces synaptic dysfunction, neuro-inflammation, and neurodegeneration.

 

MCI/Mild Alzheimer’s trials:

GABriella

– recruiting soon

Official Name : A Phase II, randomised, double-blind, placebo-controlled, multiple dose, multi-cenver, parallel-group study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO7269162 following daily oral administration in participants at risk for or at the Prodryomal stage of Alzheimer's disease.

Brief Summary : This trial is a Phase IIa study in which safety and long-term biomarker effects of RO7269162 will be evaluated in participants at risk for or at the prodromal stage of AD. RO7269162 is a gamma-secretase modulator, which is being developed for the treatment of Alzheimer’s disease (AD). Gamma-secretase modulation results in a decrease of amyloid production and potentially delays or prevents aggregation of toxic longer amyloid plaque accumulation and thereby reduces synaptic dysfunction, neuro-inflammation, and neurodegeneration.

Celia

– recruiting soon

Official Name : A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of BIIB080 in Subjects with Mild Cognitive Impairment Due to Alzheimer’s Disease or Mild Alzheimer’s Disease Dementia

Brief Summary : The purpose of this study is to look at whether BIIB080 (the study drug) can help people with AD, how safe it is, and how the body handles taking it (known as tolerability). BIIB080 is an antisense oligonucleotide (ASO) targeting tau expression, a protein which is linked to the pathophysiology of Alzheimer’s disease. Previous trials have shown how there is a dose-dependent reduction on tau in patients who have taken BIIB080.

You can read more about the Celia study here.

Trailblazer

– recruiting soon

Official Name : Global Study to Investigate Safety and Efficacy of Donanemab in Early Symptomatic Alzheimer ’s disease

Brief Summary : TRAILBLAZER-ALZ 2 is a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of N3pG antibody (Donanemab) in participants with early symptomatic AD (prodromal AD and mild dementia due to AD) with the presence of brain tau pathology.

You can read more about the Trailblazer study here.

If you want to read more about Donanemab and how it works, you can do so here. 

 

Phases of clinical trials 

Clinical trials for Alzheimer's disease typically progress through several phases, each serving a specific purpose:

  • Phase 0: This phase involves a small number of participants and focuses on testing a very low dose of a new treatment to understand how it behaves in the body. It's more about gathering initial safety data than assessing effectiveness.
  • Phase 1: Phase 1 trials involve a small group of participants and primarily assess the safety of a new treatment. Researchers also look at how the drug is processed in the body and the optimal dosage.
  • Phase 2: In this phase, researchers expand the number of participants to further evaluate the safety of the treatment and begin to assess its effectiveness. They look for preliminary evidence that the treatment may be beneficial for Alzheimer's disease.
  • Phase 3: Phase 3 trials involve a larger group of participants and are designed to confirm the effectiveness of the treatment and monitor side effects. These trials provide crucial data for regulatory approval.
  • Phase 4: Also known as post-marketing surveillance trials, Phase 4 trials occur after a treatment has been approved and is available to the public. These trials continue to monitor the long-term safety and effectiveness of the treatment in real-world settings.

Each phase builds upon the knowledge gained from the previous phase, with the ultimate goal of bringing safe and effective treatments to people living with Alzheimer's disease.

 

Benefits and risks

As with any medication, these drugs offer benefits alongside potential risks. Below, we provide a summary of the most common side effects to help you make an informed decision.

 

Benefits

 Risks
 Access to potential new treatments  New treatments are not guaranteed to be effective
 Close monitoring and support by a specialist clinical team  Less may be known about the side effects of a new drug
 Regular safety checks  There is a change that you will be taking placebo medication
 A change to help people in the future with Alzheimer's disease  Trials can be time consuming and require commitment from the participant and study partner

Participating in our trials

Transport graphic

Visits to the Imperial memory unit

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Cognitive and memory tests

Medcation graphic

Taking a tablet or receiving an injection

Graphic for blood test

Blood tests

A study partner to answer questionnaires

Scan graphic

MRI and/or PET scans

Physical examinations by a doctor/nurse

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Online or in person questionnaires, activities, keeping a diary

Benefits and risks

Just as with other medications, these drugs comes with some benefits and risks. Below is a summary of the most common side effects.

Risks

  • New treatments are not guaranteed to be effective
  • Less may be known about the side effects of a new drug
  • There is a change that you will be taking placebo medication
  • Trials can be time consuming and require committment from teh participant and study partner

Benefits

  • Access to potential new treatments
  • Close monitoring and suport by a specialist clinical team
  • Regular safety checks
  • A change to help people in the future with Alzheimer's disease
  • Reimbursement for travel expences (travel caps apply)

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