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Multicenter randomized, double-blind, placebo controlled trial evaluating the effect of a 30-week caffeine treatment on cognition in early-to moderate Alzheimer's disease
EU CTIS ID: 2024-514099-41-00
What this study is testing
Evaluate the caffeine efficacy (30 weeks of treatment) compared to placebo on cognitive decline in beginning to moderate stage Alzheimer's disease dementia (16 ≤ MMSE ≤ 26)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Men and / or women
- Age> 50 at inclusion
- Dementia related to probable Alzheimer's disease according to the criteria of the National Institute on Aging-Alzheimer's Association; the diagnosis must be supported by brain imaging (CT or MRI) and a blood test (including ionogram, renal and hepatic function, calcemia, CRP, TSH, B12 vitamins and folate) performed in routine care
- MMSE score between 16 and 26 (terminals included)
- Presence of a partner informing and helping> 10h / week
- If the participant is being treated with acetylcholine esterase inhibitors (AChEIs) and/or memantine, the treatment must be at an effective and stable dose for 2 months prior to the screening visit and must remain stable for the duration of the study
You likely can't join if
- Patients refusing to adopt a diet low in caffeine (eviction of tea, caffeinated sodas, chocolate in large quantities)
- Behavioral disorders incompatible with neuropsychological assessment
- Participation in an interventional therapeutic trial
- Non native French-speaking patient or illiterate.
- For women of childbearing age: pregnancy in progress or planned (A pregnancy test will be performed)
- Patients taking prohibited treatment: - Psychotropic treatments (antidepressants, euroleptics, anxiolytics, hypnotics and mood regulators) introduced or modified <2 months before inclusion - Chronic intake of drugs inducing or inhibiting CYP1A2 - Inhibitory drugs: Artemisinin, Atazanavir, Cimetidine, Ciprofloxacin, Enoxacin, Ethinyl Estradiol, Fluvoxamine, Mexiletine, Thiabendazole, Norfloxacine, Stiripentol - Inducing drugs: Barbiturates, Carbamazepine, Primidone, Rifampicin - All specialties containing caffeine: ACTRON®, ALEPSAL®, ALGODOL CAFEINE®, ANTIGRIPPINE A®, ASPRO CAFEINE®, CEFALINE HAUTH®, COOPER® COFFEE CITRATE, CLARADOL CAFEINE®, GCFORM®, GURONSAN®, GYNERGENE CAFEINE® , LAMALINE®, MERCALM®, METASPIRINE®, PARACETAMOL / CAFEIN / CODEINE MYLAN®, PERCUTAFEINE®, PRONTALGINE® - Drugs that influence the metabolism of caffeine (after 2): quinolones, antiarrhythmics (Mexiletine, Diltiazem, Verapamil), fluvoxamine (antidepressant), omeprazole (proton pump inhibitor), Furafylline and Theophylline (bronchodilators) - Drugs likely to interact with caffeine: in the class of anti-epileptics: Carbamazepine, Diazepam, Phenytoin, Ethosuximide, Valproate, Gabapentin, Topiramate, Lithium
See the full eligibility criteria
Who can join
- Men and / or women
- Age> 50 at inclusion
- Dementia related to probable Alzheimer's disease according to the criteria of the National Institute on Aging-Alzheimer's Association; the diagnosis must be supported by brain imaging (CT or MRI) and a blood test (including ionogram, renal and hepatic function, calcemia, CRP, TSH, B12 vitamins and folate) performed in routine care
- MMSE score between 16 and 26 (terminals included)
- Presence of a partner informing and helping> 10h / week
- If the participant is being treated with acetylcholine esterase inhibitors (AChEIs) and/or memantine, the treatment must be at an effective and stable dose for 2 months prior to the screening visit and must remain stable for the duration of the study
- Patient giving written consent
- Social insured patient
- Patient willing to comply with all procedures of the study and its duration
What rules you out
- Patients refusing to adopt a diet low in caffeine (eviction of tea, caffeinated sodas, chocolate in large quantities)
- Behavioral disorders incompatible with neuropsychological assessment
- Participation in an interventional therapeutic trial
- Non native French-speaking patient or illiterate.
- For women of childbearing age: pregnancy in progress or planned (A pregnancy test will be performed)
- Patients taking prohibited treatment: - Psychotropic treatments (antidepressants, euroleptics, anxiolytics, hypnotics and mood regulators) introduced or modified <2 months before inclusion - Chronic intake of drugs inducing or inhibiting CYP1A2 - Inhibitory drugs: Artemisinin, Atazanavir, Cimetidine, Ciprofloxacin, Enoxacin, Ethinyl Estradiol, Fluvoxamine, Mexiletine, Thiabendazole, Norfloxacine, Stiripentol - Inducing drugs: Barbiturates, Carbamazepine, Primidone, Rifampicin - All specialties containing caffeine: ACTRON®, ALEPSAL®, ALGODOL CAFEINE®, ANTIGRIPPINE A®, ASPRO CAFEINE®, CEFALINE HAUTH®, COOPER® COFFEE CITRATE, CLARADOL CAFEINE®, GCFORM®, GURONSAN®, GYNERGENE CAFEINE® , LAMALINE®, MERCALM®, METASPIRINE®, PARACETAMOL / CAFEIN / CODEINE MYLAN®, PERCUTAFEINE®, PRONTALGINE® - Drugs that influence the metabolism of caffeine (after 2): quinolones, antiarrhythmics (Mexiletine, Diltiazem, Verapamil), fluvoxamine (antidepressant), omeprazole (proton pump inhibitor), Furafylline and Theophylline (bronchodilators) - Drugs likely to interact with caffeine: in the class of anti-epileptics: Carbamazepine, Diazepam, Phenytoin, Ethosuximide, Valproate, Gabapentin, Topiramate, Lithium
- CAFCA-MRI and CAFCA-TEP ancillary studies: Patients with a contraindication for MRI and / or PET scans
- Current major depressive episode according to DSM-5 criteria
- Other chronic pathology of the central nervous system
- Major anxiety according to the clinician (in coherence with the corresponding NPI-R items which must indicate a gravity> 2 and a repercussion> 3)
- Sleep disorders defined by gravity> 2 and a repercussion> 3 on the NPI-R; a patient paired for OSAS may be included if the equipment has been in use for> 3 months and is well tolerated (stable)
- Decompensated heart disease or severe rhythm disorder (excluding slow, treated and stable chronic atrial fibrillation)
- Any significant comorbidity that may be confounding by the clinician
- Active smoking
- Excessive alcohol consumption (> 3 units per day on average)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.