Efficacy of Sublingual 5-MeO-DMT for Reducing Anxiety and Depression in MCI
Sponsored by Biomind Labs Inc.
About This Study
This Phase I/II clinical trial aims to test the effectiveness of a new sublingual formulation of 5-MeO-DMT in reducing symptoms of anxiety, depression, and cognitive decline in individuals with mild to moderate Alzheimer's disease. The study will include participants who have a Clinical Dementia Rating (CDR) score between 0.5 and 1, indicating mild to moderate cognitive impairment, and who meet specific educational and cognitive criteria. Participants must have an ACE-III score of ≤86 for individuals with a high level of education (≥12 years) or \<62 for those with a low educational level (≤12 years). Additionally, participants must show moderate to high levels of anxiety, as indicated by the State-Trait Anxiety Inventory (STAI), with STAI-S (State) scores ≥20 for men and ≥23 for women, and STAI-T (Trait) scores ≥20 for men and ≥26 for women. Participants also need to exhibit moderate to severe depressive symptoms, as indicated by a Beck Depression Inventory (BDI) score of ≥21. To ensure that participants are cognitively functional but showing signs of impairment, they are assessed with the CDR and ADLQ scales to confirm they can maintain independence in daily activities. All participants must have scores above the threshold on cognitive screening tests like the ACE III and IFS, ensuring no significant cognitive impairment at the baseline. The study will measure the effects of 5-MeO-DMT through a range of cognitive and psychiatric assessments: Cognitive Assessments: These include the Rey Auditory Verbal Learning Test (RAVLT) for episodic memory, the Trail Making Test (TMT) for attention and cognitive flexibility, the Semantic and Phonological Fluency Test (SFT-FAS) for verbal fluency, the Paced Auditory Serial Addition Test (PASAT) for processing speed, and the Digit Span Subtests (DSS) for attention and working memory. These tests will provide valuable insights into how 5-MeO-DMT affects cognitive functions. Psychiatric Assessments: These will assess symptoms of suicidal ideation (SSI), mood (BDI II), anxiety (STAI), and mindfulness (FFMQ), as well as self-reported cognitive complaints (CQC). These evaluations will help determine the psychological and emotional impact of 5-MeO-DMT on participants. In addition, the study will include biochemical assessments such as microalbuminuria, blood glucose levels, liver and kidney function, cholesterol, and several biomarkers of inflammation. Cardiovascular evaluations will also be conducted during the trial, ensuring comprehensive monitoring of potential side effects. This structured approach will help researchers assess the cognitive and psychological effects of 5-MeO-DMT in individuals with mild to moderate Alzheimer's disease. By focusing on participants with elevated anxiety, depression, and early cognitive decline, this trial aims to provide insights into the therapeutic potential of 5-MeO-DMT for neurodegenerative conditions.
Conditions Studied
Interventions
- •Sublingual administration
- •Electroencephalography
- •Biochemical mesurements
- •Acute Subjective Ratings of Psychedelic Effects
- •Vital signs
- •Cognitive Assessments
- •Psychiatric Assessments
Eligibility
View full eligibility criteria
Inclusion Criteria: * Adults aged 40 to 80 years * Diagnosis of mild to moderate Alzheimer's disease * Clinical Dementia Rating (CDR) score between 0.5 and 1 * ACE-III score ≤ 86 for individuals with high educational levels (≥12 years of schooling) * ACE-III score \< 62 for individuals with low educational levels (≤12 years of schooling) * Moderate to high levels of anxiety, as defined by: * State-Trait Anxiety Inventory (STAI-S) State score ≥20 for men, ≥23 for women * STAI-Trait score ≥20 for men, ≥26 for women * Mild to moderate depressive symptoms, as indicated by a Beck Depression Inventory (BDI) score ≥21 * Must provide written informed consent to participate in the study Exclusion Criteria: * Liver dysfunction * Cardiovascular conditions (e.g., uncontrolled hypertension, angina, significant ECG abnormalities, recent transient ischemic attack or stroke, peripheral/pulmonary vascular disease without active claudication). * Blood pressure \>140 mmHg systolic or \>90 mmHg diastolic * Epilepsy or history of seizures * Kidney failure * Insulin-dependent diabetes * Chronic obstructive pulmonary disease (COPD) * Increased intracranial or cerebrospinal pressure * Hyperthyroidism * Psychotic symptoms or family history of psychotic disorders * Prodromal symptoms of schizophrenia or dissociative identity disorder * Severe depression or anxiety requiring immediate treatment with antidepressants or daily anxiolytics, particularly in cases with suicidal ideation * Medications: Regular use of psychoactive medications, including benzodiazepines, serotonin-active medications (e.g., ondansetron), or monoamine oxidase inhibitors (MAOIs) * Drug Interactions: Use of potent metabolic inducers or inhibitors, such as: Inducers: rifampicin, anticonvulsants (e.g., carbamazepine, phenytoin), nevirapine, efavirenz, taxol, dexamethasone. Inhibitors: HIV protease inhibitors, itraconazole, ketoconazole, erythromycin, clarithromycin, troleandomycin.