Efficacy of Sublingual 5-MeO-DMT for Reducing Anxiety and Depression in MCI
Efficacy of Sublingual 5-MeO-DMT for Reducing Anxiety and Depression in MCI
NCT ID: NCT06812221 Phase: PHASE1 Status: COMPLETED Enrollment: 20 Completion: 2025-03-15
Conditions
Mild Cognitive Impairment, Anxiety State, Depression Anxiety Disorder
Interventions
Sublingual administration, Electroencephalography, Biochemical mesurements, Acute Subjective Ratings of Psychedelic Effects, Vital signs, Cognitive Assessments, Psychiatric Assessments
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 o
Primary Outcome
Change in Phonological Verbal Fluency Test (FAS) from Baseline to Week 5