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Current Trials

The Clinical Trials team, led by Dr Cath Mummery, are running a number of clinical trials for which you may be eligible. These treatment trials are vitally important to allow us to develop and test medicines that may alter the progression of diseases causing dementia, or alleviate or even prevent the onset of symptoms.

What clinical trials involve

The aim of a drug trial is to test whether a particular drug has a beneficial therapeutic effect (efficacy). This involves investigating how a drug impacts on dementia symptoms, but will also include monitoring its safety and/or assessing its effect on other biological markers of disease progression. In order to test the effect a drug may have, participants are assigned to one of two main groups: one of these groups will be given the active medication and the other will be administered a placebo that contains no active medication. Participants are assigned to either group at random, and neither you nor the study team will know the group to which you are assigned during the trial. The drugs in our trials are administered orally (taking a pill), through infusion (via an intravenous drip) or by lumbar puncture injection.

Most clinical trials involve a number of visits to measure the safety and efficacy of a drug over time. Duration of the studies ranges from 6 months to 5 years. In addition some studies then ‘extend’ where the participants are offered the opportunity to knowingly take the active drug for a further period of time.

Before you enter the trial, there may be screening phone calls and visits to ascertain whether you fulfil all the criteria required for the study. The number of overall visits and the flexibility of visit timings will often depend on the particular study: many trials have a schedule with specific time windows that determine when certain visits take place. At a minimum, all trials will involve answering questions about your memory and thinking and a clinical examination with a doctor. Additional tests may involve MRI scans, PET scans and lumbar punctures. Many trials require you to bring a study partner who knows you well, and who may be asked questions about your general health, memory and thinking.

As a participant in a clinical trial you will be asked to make a number of visits to our research facilities in Queen Square . Some of the trials also include visits to other locations in London. During that time, you will see several research staff on a prearranged schedule, with plenty of time for breaks. The Dementia Research Centre would pay for, or book your travel (and travel for the person accompanying you) and reimburse you for the cost of meals and refreshments during the visit. Some trials may require you to attend the Dementia Research Centre for two consecutive days. In this case we would make arrangements for you and the person accompanying you to stay in a nearby hotel if this would be more convenient for you; the costs of the hotel stay would be met by the Dementia Research Centre .

If you would like more information about taking part in our drug studies please contact drctrialenquiries@ucl.ac.uk, or +44 (0) 20 3448 3105.  The DRC also actively supports Join Dementia Research (www.joindementiaresearch.nihr.ac.uk) which matches registrants to appropriate studies throughout the UK. 

ENGAGE

A phase III study of aducanumab in early Alzheimer’s disease

Official title: A Phase 3 Multicenter, Randomized, Double-Blind, PlaceboControlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects With Early Alzheimer's Disease

A study sponsored by Biogen, Inc. is investigating whether a drug called aducanumab has the potential to slow down disease progression in research participants diagnosed with Alzheimer’s disease, by comparing it to placebo (inactive medication) and evaluating its safety (side effects). Aducanumab is an antibody which binds to a protein called amyloid and removes it from the brain, potentially preventing the build up of plaques found in the brains of people with Alzheimer’s disease.

We are recruiting people with early Alzheimer’s disease who are between 50 and 85 years old.

What does this trial involve?

  • A screening period of up to 60 days (2 months).
  • A visit to Queen Square for intravenous drug infusion once every 4 weeks for 76 weeks (18 months)
  • Medical assessments; including neurological and physical examinations, blood and urine tests and electrocardiogram (ECG).
  • Memory and thinking assessments. • Research-only genetic testing from a blood sample.
  • 9 MRI scans and at least 1 PET scan.
  • Optional lumbar puncture to donate a small amount of spinal fluid.
  • Option for a possible 2 year extension to continue receiving the active drug.
Masitinib [recruitment closed] 

A multicentre, double-blind, placebo-controlled, randomised, parallel-group phase 3 study to evaluate the safety and efficacy of masitinib in patients with mild to moderate Alzheimer’s disease

A study sponsored by AB Science is investigating whether a drug called Masitinib has the potential to be a helpful treatment for memory symptoms when taken alongside the usual medication for Alzheimer’s disease, by comparing it to placebo (inactive medication plus your usual medication) and evaluating its safety (side effects). This drug acts on the inflammatory pathway and aims to reduce  the symptoms associated with Alzheimer’s disease.

Recruiting people with Alzheimer’s disease over the age of 50.

What does this trial involve?

  • One screening visit.
  • A minimum of 7 further visits over 24 weeks (6 months).
  • Taking drug tablets orally.
  • Optional MRI scans.
  • Memory and thinking assessments.
  • Medical assessment, including blood tests and electrocardiogram.
PADMMA (recruitment on hold)

A pilot study investigating inflammation in early Alzheimer’s disease

Official title: A Pilot longitudinal study in Alzheimer’s Disease of central Markers of Microglial Activation: PADMMA

A study sponsored by University College London (UCL) in collaboration with Teva Pharmaceutical Industries Ltd. is investigating markers of inflammation in the brain, and how they are linked to other markers of Alzheimer’s disease; such as physical brain changes and memory and cognitive symptoms. The aim is to develop robust indicators of inflammation in Alzheimer’s disease in order to trial anti-inflammatory treatments.

This study is not currently investigating any active treatments, but those who participate in this study will be given early information about any subsequent drug trials and invited to consider participating if they are eligible.

We are recruiting people with early Alzheimer’s disease who are over the age of 30.

What does this trial involve?

  • 3 screening visits over 60 days (2 months).
  • 1 further study visit, followed by 2 visits a year later.
  • Medical assessments; including physical and neurological examinations, blood tests and electrocardiogram (ECG).
  • Memory and thinking assessments.
  • 2 or 3 MRI scans and 3 PET scans.
  • 2 lumbar punctures to donate a small amount of spinal fluid.
    IONIS (currently recruiting)

    A phase I safety study in mild Alzheimer’s disease

    Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of Intrathecally Administered ISIS 814907 in Patients with Mild Alzheimer’s Disease

    A study sponsored by Ionis Pharmaceuticals, Inc. is evaluating the safety (side effects) of a drug called ISIS 814907. This drug may have the potential to slow disease progression by reducing production of a protein called tau which builds up in the brains of people with Alzheimer’s disease. Participants are treated with the study drug or placebo (inactive medication).

    We are recruiting people with mild Alzheimer’s disease who are between 50 and 74 years old.

    What does this trial involve?

    • A screening period of up to 8 weeks.
    • A 13-week (3 month) treatment period, including monthly overnight visits to Queen Square for administration of the study drug (4 treatments) and up to 4 additional assessment visits.
    • A 23-week (5 month) post-treatment period, involving 4 follow-up visits to Queen Square
    • Medical assessments; including neurological and physical examinations, blood and urine tests and electrocardiogram (ECG).
    • Memory and thinking assessments.
    • Research-only genetic testing from a blood sample.
    • 2 MRI scans and 2 PET scans.
    • 3 lumbar punctures to assess safety and 4 lumbar punctures to administer the drug and assess safety.
    • Option for a possible extension to continue receiving the active drug.
    EARLY (recruitment closed)

    A phase IIb/III study of JNJ-54861911 in participants who are asymptomatic at risk for developing Alzheimer’s diseaseContent placeholder

     

    Official title: A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Study Investigating the Efficacy and Safety of JNJ54861911 in Subjects who are Asymptomatic At Risk for Developing Alzheimer’s Dementia

    A study sponsored by Janssen Research & Development is investigating whether a drug called JNJ-54861911 has the potential to slow disease progression in people who are at risk for developing Alzheimer’s disease. The drug will be compared to placebo (inactive medication) and its safety evaluated (side effects). JNJ-54861911 inhibits an enzyme which is involved in the production of amyloid proteins which form plaques in the brains of people with Alzheimer’s disease, therefore potentially reducing the amyloid build up.

    We are recruiting people who are aged between 60 and 85 and do not currently have any symptoms of Alzheimer’s disease, but are worried that they may develop Alzheimer’s disease in the future.

    What does this trial involve?

    • 6 screening visits over 90 days (3 months).
    • Further monthly visits for 1 year, followed by 3-monthly visits for 3½ years.
    • Taking drug tablets orally.
    • Medical assessments; including physical and neurological examinations, blood and urine tests and electrocardiogram (ECG).
    • Memory and thinking assessments.
    • Research-only genetic testing from a blood sample.
    • 6 MRI scans and 6 PET scans. 
    • 4 optional lumbar punctures to donate a small amount of spinal fluid. 
    TRx-020

    This is an open-label extension continuation of the TRx007 and TRx015 studies. This study involves daily administration of the same experimental medication as in the TRx007 and TRx015 studies to assess the safety of this study drug

    Genentech

    This is a multicenter, open-label extension study of the effects of a monoclonal antibody against amyloid-beta (crenezumab) in Patients with Mild to Moderate Alzheimer’s Disease. This study is designed to assess the long-term safety and tolerability of crenezumab in patients with sporadic AD

    DESPIAD (currently recruiting)

    Official title: DEpletion of Serum Amyloid P component In Alzheimer’s Disease: DESPIAD. Double-blind placebo controlled randomised phase IIb trial of SAP depletion by miridesap in Mild Alzheimer’s Disease.

    A study funded by the National Institute of Health Research (NIHR) is investigating the safety of a medication called miridesap and whether it can slow down the progression of Alzheimer’s disease.  The drug will be compared with placebo (inactive medication) and its safety will be evaluated (side effects). Serum amyloid P Component (SAP) is increased in the brain in Alzheimer’s disease and miridesap removes the SAP from the blood stream and the brain.

    We are recruiting people who have a diagnosis of mild Alzheimer’s disease over the age of 50 years old.
     

    What does this trial involve?
    • 1 screening period up to 8 weeks.
    • A minimum of 5 further visits over the course of a year.
    • Medical assessments; including physical and neurological examinations, blood and urine tests and electrocardiogram (ECG).
    • Memory and thinking assessments.
    • Other assessments include: MRI brain scan, PET brain scan, and optional lumbar puncture
    • Drug administered via subcutaneous (under the skin) injections with a very fine needle (similar to insulin injection for Diabetes) on a daily basis.

    TAURIEL (no longer recruiting)

     A Phase II, Multicenter, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of MTAU9937A in Patients with Prodromal to Mild Alzheimer’s disease


    A study sponsored by Genentech, Inc. is investigating the safety (side effects) and efficacy of a drug called MTAU9937A. This drug may have the potential to stop and slow the production of a protein called tau which builds up in the brains of people with Alzheimer’s disease. Participants are treated with the study drug or placebo (inactive medication).
    We are recruiting people with a diagnosis of prodromal or mild Alzheimer’s disease, aged between 50-80.
    What does this trial involve?
    • A screening period of up to 56 days.
    • A 73-week (18 month) treatment period
    • Medication administered via infusion on a monthly basis
    • Medical assessments; including neurological and physical examinations, blood and urine tests and electrocardiogram (ECG).
    • Memory and thinking assessments.
    • Research-only genetic testing from a blood sample.
    • 4 MRI scans and 3-4 PET scans (3 optional lumbar punctures).
    • Option for a possible open-label extension to continue receiving the active drug.
     

    DIAN-TU (recuritment on hold)

    A phase II/III study of potential disease-modifying therapies in individuals at risk for and with dominantly inherited Alzheimer’s disease

    Official title: A Phase II/III Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of 2 Potential Disease Modifying Therapies in Individuals at Risk for and with Dominantly Inherited Alzheimer’s Disease

    The Dominantly Inherited Alzheimer’s Network Trials Unit (DIAN-TU) is running an international multi-centre study investigating whether 2 drugs, Gantenerumab and Solanezumab, have the potential to prevent, delay, or reverse the changes in the brain that occur in dominantly inherited Alzheimer’s disease. Gantenerumab and Solanezumab are antibodies that bind to amyloid and remove it from the system, potentially preventing the build up of plaques found in Alzheimer’s disease. The drugs will be compared to placebo (inactive medication) and their safety evaluated (side effects).

    We are recruiting people who are confirmed carriers of a PSEN1, PSEN2 or APP mutation, or a member of a family with a confirmed PSEN1, PSEN2 or APP mutation, and are aged between 18 and 80.

    What does this trial involve?
    • 1 screening visit.
    • Monthly visits over 4 years to Queen Square and another centre in Cambridge.
    • Research-only genetic testing from a blood sample.
    • Monthly intravenous administration of the study drug or placebo (inactive medication) - participants who test negative for PSEN1, PSEN2 or APP will be given placebo.
    • Medical assessments; including physical and neurological examinations, blood and urine tests and electrocardiogram (ECG).
    • Memory and thinking assessments.
    • Multiple MRI brain and PET brain scans, Lumbar punctures

    EVOLVE

    A phase II study of aducanumab in Mild Cognitive Impairment due to Alzheimer’s disease or Mild Alzheimer’s disease

    Official title: A Phase 2, Multicenter, Randomised, Parallel-Group, Double-Blind, Con-trolled Study of Aducanumab (BIIB037) in Subjects With Mild Cognitive Impairment due to Alzheimer’s Disease or With Mild Alzheimer’s Disease Dementia to Evaluate the Safety of Continued Dosing in Subjects with Asymptomatic Amyloid-Related Imaging Abnormalities
    Recruitment on hold

    A study sponsored by Biogen, Inc. is assessing the safety impact of continuing aducanumab dosing in asymptomatic Amyloid-related Imaging Abnormalities (ARIA) in participants with mild cognitive impairment (MCI) due to Alzhei-mer's disease (AD) or with mild AD dementia . Aducanumab is an antibody which binds to a protein called amyloid and removes it from the brain, poten-tially preventing the build up of plaques found in the brains of people with Alzheimer’s disease.

    We are recruiting people with mild cognitive impairment or mild Alzheimer’s disease who are between 50 and 85 years old.

    What does this trial involve?
    • A screening period of up to 60 days (2 months).
    • A visit to Queen Square for intravenous drug infusion once every 4 weeks for 76 weeks (18 months).
    • All participants will receive active medication
    • Medical assessments; including neurological and physical examinations, blood and urine tests and electrocardiogram (ECG).
    • Memory and thinking assessments.
    • Research-only genetic testing from a blood sample.
    • 6 MRI brain scans and 1 PET brain scan.
    • Optional 1 year extension to continue receiving the active drug.

    ALECTOR 001 (currently recruiting)

    A phase I study of AL001 in Healthy Volunteers and Heterozygous carriers of a Loss-of-function Granulin Fronto-temporal Dementia

    Official title: A First in Human Phase 1 Study in Healthy Volunteers and Heterozygous Carriers of a Loss-of-function Granulin Mutation Causative of Frontotemporal Dementia to assess AL001 Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics.
    A study sponsored by Alector, Inc. is assessing the safety of AL001 in healthy volunteers and heterozygous carriers of a Loss-of-function Granulin mutation that causes Frontotemporal Dementia (FTD). The drug may reduce the rate of neurodegeneration by increasing, and normalizing, their central nervous system (CNS) Progranulin levels.

    We are recruiting patients with Fronto-temporal Dementia who have a spe-cific genetic change - a Heterozygous Loss-of-function Granulin mutation who are between 18 to 80 years old, to take the active medication either via single or multiple dose.

    What does this trial involve?
    • A screening period of up to 42 days
    • The treatment period is due to last 113 or 141 days (depending on the cohort you are enrolled onto)
    • Medical assessments; including neurological and physical examinations, blood and urine tests and electrocardiogram (ECG)
    • 2-3 MRI brain scans (depending on cohort you are enrolled onto)
    • 2-3 Lumbar Punctures (depending on cohort you are enrolled onto)