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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the effects of caffeine on cognitive decline in people with Alzheimers disease at early to moderate stages, characterized by a Mini-Mental State Examination MMSE score between 16 and 24. This phase 3, multicenter, randomized, double-blind, placebo-controlled trial aims to study the 30-week impact of caffeine treatment on cognition. The study addresses the potential benefits and risks of caffeine, considering its complex effects on the central nervous system, including possible anxiety and insomnia at high doses, which may be more pronounced in Alzheimers patients. Participants begin with a 3-week dose escalation period, followed by a 27-week treatment phase. The caffeine group receives capsules starting at 100 mg, titrated up by 100 mg increments to a target dose of 400 mg per day divided into two doses, while the placebo group undergoes a similar regimen with placebo capsules. After the treatment period, caffeine is tapered off using the same negative titration. Both groups follow a low caffeine diet before and during the study. During the study, participants undergo regular assessments of cognitive function using the Neuropsychological Test Battery NTB scores at 30 weeks and six weeks after treatment ends to observe any lasting effects. Additional evaluations include MMSE scores, attention tests, sleepiness scales, daily living activities, quality of life, caregiver burden, clinical global impression, and safety monitoring of heart rate and blood pressure. Blood samples will measure caffeine and its derivatives. The study involves caregivers living with the patient and lasts for at least 36 weeks from randomization.

Age: 50Years +All GendersPhase 3
17 locations
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Actively Recruiting

This research aims to evaluate treatments for gambling disorder GD, an addictive condition characterized by craving that can lead to relapse. The trial compares Cognitive-Behavioral Therapy CBT combined with Virtual Reality Exposure Therapy VRET to CBT with imaginal exposure therapy. Both approaches target craving responses triggered by gambling-related cues, with the goal to reduce GD symptoms. The study is a multicenter, randomized, controlled, non-inferiority trial to determine if VRET is at least as effective as imaginal exposure. Participants receive 12 treatment sessions over about 6 months, either CBT with VRET or CBT with imaginal exposure. VRET uses simulated gambling environments to closely mimic real gambling situations, while imaginal exposure involves mentally confronting gambling cues. Both methods aim to help patients reduce craving by addressing classical conditioning between cues and craving. The study compares the two approaches for symptom reduction, gambling behavior, craving levels, anxiety, depression, and treatment quality. Throughout the study, participants undergo assessments including the South Oaks Gambling Screen SOGS at baseline, end of treatment, and several follow-ups up to 12 months post-treatment. Additional measures include gambling frequency, money spent, craving episodes, cognition related to gambling, and mood symptoms. Attendance, safety, and symptom changes are monitored for approximately 18 months, providing comprehensive data on the effects of the therapies over time.

Age: 18Years +All GendersPhase Not Applicable
10 locations