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Study on the Effects of Caffeine on Cognitive Function in Patients with Early to Moderate Alzheimer's Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for Alzheimer's disease, a condition that affects memory and thinking skills. The treatment being tested is caffeine, a substance commonly found in coffee and tea, which will be given in capsule form. The study aims to understand how caffeine affects cognitive abilities, such as memory and problem-solving, in individuals with early to moderate stages of Alzheimer's disease.

Participants in the study will receive either caffeine or a placebo, which looks like the caffeine capsule but does not contain any active ingredients. The study will last for 30 weeks, during which participants will take the capsules daily. Researchers will monitor changes in cognitive functions, such as memory and attention, to see if caffeine has a positive effect compared to the placebo. The study will also look at how caffeine affects daily living activities and any side effects that may occur.

The goal of the study is to evaluate whether caffeine can help slow down cognitive decline in people with Alzheimer's disease. Participants will be assessed at various points during the study to track their progress and any changes in their condition. This research could provide valuable insights into potential new treatments for Alzheimer's disease, helping to improve the quality of life for those affected by this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of Alzheimer's disease, and cognitive assessment scores.

    Written consent is required to participate, and a stable treatment regimen must be maintained if applicable.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either caffeine or a placebo for the duration of the study.

    This process ensures that the study remains unbiased and the effects of caffeine can be accurately assessed.

  3. Step 3

    Treatment phase

    The treatment involves taking caffeine anhydre capsules orally. The dosage and frequency are determined by the study protocol.

    This phase lasts for 30 weeks, during which cognitive functions and other health parameters are monitored.

  4. Step 4

    Monitoring and assessments

    Regular assessments are conducted to evaluate cognitive functions, including tests like the MMSE and NTB scores.

    Additional health parameters such as heart rate and blood pressure are also monitored throughout the study.

  5. Step 5

    End of treatment evaluation

    At the end of the 30-week treatment period, a final assessment is conducted to measure changes in cognitive function and other health indicators.

    The primary focus is on the variation in cognitive scores from the start to the end of the treatment.

  6. Step 6

    Post-treatment follow-up

    A follow-up assessment occurs 6 weeks after the treatment ends to evaluate any lasting effects of caffeine.

    This includes a review of cognitive scores and other health parameters to determine the persistence of any changes.

Who can join the trial?

9 criteria

  • Men and/or women can participate.
  • Participants must be older than 50 years at the time of joining the study.
  • Participants should have dementia related to probable Alzheimer's disease. This diagnosis must be confirmed by brain imaging tests like a CT or MRI scan, and a blood test that checks various health markers.
  • The MMSE score, which is a test to measure memory and thinking skills, should be between 16 and 26.
  • Participants need to have a partner or caregiver who can inform and help them for more than 10 hours each week.
  • If participants are taking medications called acetylcholine esterase inhibitors (AChEIs) or memantine, the dose must be effective and stable for at least 2 months before starting the study and should remain stable during the study.
  • Participants must provide written consent, meaning they agree in writing to take part in the study.
  • Participants should have social insurance.
  • Participants must be willing to follow all the procedures of the study and commit to its duration.

Who cannot join the trial?

6 criteria

  • Patients who do not have a diagnosis of Alzheimer's disease cannot participate.
  • Patients who are not in the beginning to moderate stages of Alzheimer's disease, as measured by a test called MMSE (Mini-Mental State Examination), cannot participate. The MMSE score should be between 16 and 26.
  • Patients who are not within the specified age range cannot participate. The trial is open to certain age groups only.
  • Patients who are not part of the specified clinical trial group cannot participate.
  • Both male and female patients are eligible, so gender is not an exclusion criterion.
  • Patients who are not considered part of a vulnerable population cannot participate.
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Investigated drugs

Caffeine is being studied for its potential effects on cognitive decline in patients with Alzheimer's disease. The trial aims to evaluate whether caffeine can help improve or maintain cognitive function in individuals with early to moderate stages of this condition. Participants will receive caffeine treatment over a period of 30 weeks to assess its impact on their cognitive abilities.

What is already known about the treatment

Caffeine – Caffeine is administered orally, typically in the form of tablets or capsules. It is currently being studied in clinical trials for its potential effects on cognitive function in Alzheimer's disease, particularly in the early to moderate stages. The main therapeutic indication being explored is its ability to slow cognitive decline in individuals with Alzheimer's disease. At the molecular level, caffeine acts as a central nervous system stimulant by blocking adenosine receptors, which can enhance alertness and cognitive performance. It is classified pharmacologically as a central nervous system stimulant.

Investigated diseases

Alzheimer's disease – Alzheimer's disease is a progressive neurological disorder that leads to the degeneration of brain cells, causing memory loss and cognitive decline. It typically begins with mild memory lapses and confusion, which gradually worsen over time. As the disease progresses, individuals may experience difficulties with language, disorientation, mood swings, and behavioral changes. In the moderate stages, daily tasks become challenging, and individuals may require assistance with personal care. Eventually, severe memory loss and loss of ability to carry out daily activities occur. The progression of Alzheimer's disease varies among individuals, but it generally leads to significant impairment in cognitive and functional abilities.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514099-41-00Protocol code2018_95Estimated enrolment248 patientsSponsorCentre Hospitalier Universitaire De Lille

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