CompletedPhase 1 / Phase 2

Efficacy of Sublingual 5-MeO-DMT for Reducing Anxiety and Depression in MCI

NCT06812221 · 5-MeO-DMT · Biomind Labs Inc.

Closed to entry

Status

Not accepting participants

Phase 1 / Phase 2

Phase

Target enrolment

Study sites

Outside the US

What it is testing

Summary

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Change in Phonological Verbal Fluency Test (FAS) from Baseline to Week 5
Measured over The FAS will be administered at baseline (Week 0), during treatment (Weeks 1-4), and at follow-up (Week 5) to assess changes in executive function during and after sublingual 5-MeO-DMT administration.
Change in Paced Auditory Serial Addition Test (PASAT) from Baseline to Week 5
Measured over The PASAT will be administered at baseline (Week 0), during treatment (Weeks 1-4), and at follow-up (Week 5) to evaluate the effects of 5-MeO-DMT on cognitive processing speed and attention.
Change in Digit Span Scale (DSS) from Baseline to Week 5
Measured over The DSS will be administered at baseline (Week 0), during treatment (Weeks 1-4), and at follow-up (Week 5) to assess changes in attention and working memory following 5-MeO-DMT administration.
Mystical Experience Questionnaire (MEQ) Assessment at 40 Minutes Post-Administration
Measured over The MEQ will be completed at 40 minutes post-administration during each dosing week (Weeks 1-4) to assess the subjective mystical experiences induced by sublingual 5-MeO-DMT.
Peak Experience Scale (PES) Assessment at 40 Minutes Post-Administration
Measured over The PES will be completed at 40 minutes post-administration during each dosing week (Weeks 1-4) to capture the intensity and emotional impact of the 5-MeO-DMT experience.
Ego Dissolution Inventory (EDI) Assessment at 40 Minutes Post-Administration
Measured over The EDI will be completed at 40 minutes post-administration during each dosing week (Weeks 1-4) to evaluate the degree of ego dissolution experienced after 5-MeO-DMT consumption.

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

40 Years to 80 Years

Ages

All

Sex

Accepted

Healthy volunteers

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.

Where

1 study site

Facility	City	Region	Country
Hospital Descentralizado Dr. Marcial V. Quiroga.	San Juan	Rivadavia	Argentina

On the registry

Contact the trial directly

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NCT06812221 on ClinicalTrials.gov →

Last updated in the registry 2025-04-09. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Indication

All 3 trials from Biomind Labs Inc. →