Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04075435 · ClinicalTrials.gov registry record · Early Phase 1
Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia
A Early Phase 1 study of Anxiety and Alzheimer Disease, sponsored by Mclean Hospital.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT04075435: Recruiting Early Phase 1 study of Anxiety and Alzheimer Disease, sponsored by Mclean Hospital.
NCT04075435 is a Early Phase 1 study of Anxiety and Alzheimer Disease that is actively recruiting participants, run by Mclean Hospital. The registered enrollment target is 12 participants, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04075435, a Early Phase 1 study of Anxiety and Alzheimer Disease, is actively recruiting participants, sponsored by Mclean Hospital.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open label, eight week, clinical trial of a proprietary high CBD/low THC sublingual solution for the treatment of clinically significant anxiety and agitation in individuals with mild cognitive impairment (MCI) or mild to moderate Alzheimer's Disease (AD).
Primary Outcome
Measure of Anxiety Domain on the Neuropsychiatric Inventory-Clinician scale
Conditions Studied
Interventions
- DRUG high CBD/low THC sublingual solution
Study Locations (1)
Massachusetts
- McLean Hospital - Belmont
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-01-11 |
| Est. Completion | 2026-01-16 |
| Phase | Early Phase 1 |
What NCT04075435 shows while recruiting
NCT04075435 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (97% lower).
The record links to 4 conditions, with Anxiety appearing as the primary indexed condition, and to 1 intervention - of which high CBD/low THC sublingual solution is the first listed.
NCT04075435 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04075435 about?
NCT04075435 is a clinical study titled "Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia". This is an open label, eight week, clinical trial of a proprietary high CBD/low THC sublingual solution for the treatment of clinically significant anxiety and agitation in individuals with mild cognitive impairment (MCI) or mild to moderate Alzheimer's Disease (AD).
What is the current status of trial NCT04075435?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2021-01-11. Estimated completion is 2026-01-16.
What conditions does trial NCT04075435 study?
This clinical trial studies the following conditions: Anxiety, Alzheimer Disease, Agitation,Psychomotor, Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease.
What interventions are being tested in trial NCT04075435?
The interventions under investigation include: high CBD/low THC sublingual solution (DRUG).
Who is sponsoring clinical trial NCT04075435?
This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04075435 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Anxiety
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04075435's enrollment target sits among peer trials
12 352nd of 364 higher than 11 of 364 other Anxiety trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anxiety trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Sleep, Dreaming, and Virtual Reality for Mental Health
RECRUITING · Early Phase 1
-
Feasibility Study of Oral Ketamine Versus Placebo for the Treatment of Anxiety in Patients With Pancreatic Cancer
RECRUITING · Early Phase 1
-
Probiotics for Quality of Life in Autism Spectrum Disorders
COMPLETED · Early Phase 1
-
Acute and Long-Term Antidepressant Treatment Success in Adolescents With Anxiety (AtLAS-A)
RECRUITING · Phase 4
-
Focused Ultrasound for the Complex Patient
RECRUITING · NA
-
Digital Intervention for Physical Activity
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02602769 · 12 participants
Whole Transcriptome Profiling and Metabolic Phenotyping in Children With ROHHAD Syndrome
- NCT02605421 · 12 participants · Phase 2
Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma
- NCT02619448 · 12 participants · Early Phase 1
Concurrent Chemotherapy Plus HFR Radiation Therapy in Inoperable NSCLC
- NCT03311503 · 12 participants · Phase 1
Phase I/II Trial of Lentiviral Gene Transfer for SCID-X1 With Low Dose Targeted Busulfan Conditioning
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI