Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT04123314|
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : August 14, 2023
|Condition or disease||Intervention/treatment||Phase|
|Depressive Symptoms Depression Alzheimer Disease Mild Cognitive Impairment||Drug: Psilocybin||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Serotonin 2A Receptor (5-HT2A) Agonist Psilocybin for Depression in Patients With Mild Cognitive Impairment or Early Alzheimer's Disease|
|Actual Study Start Date :||March 24, 2021|
|Estimated Primary Completion Date :||December 30, 2024|
|Estimated Study Completion Date :||December 30, 2024|
Participants will complete an 8-week course of study treatment including weekly psychological support and two moderate to high dose psilocybin administrations in weeks 4 and 6.
Dosing at the first session will be 15 mg/70 kg. For the second session participants will either remain at the initial dose, or increase to 25 mg/70 kg at the discretion of the study team.
- Change in Cornell Scale for Depression in Dementia (CSDD) score [ Time Frame: Baseline and 1 week after second psilocybin session ]The Cornell Scale for Depression in Dementia (CSDD) is administered via patient and informant interviews to assess the presence and severity of depressive mood and behavioral symptoms during the past week. Has 19 items, each scored from 0 to 2 with higher scores indicating severe symptom.Total score range from 0 to 38.
- Change in Quality of Life Alzheimer's Disease (QOL-AD) scale score [ Time Frame: Baseline and 2 weeks after second psilocybin session ]The Quality of Life Alzheimer's Disease (QOL-AD) scale is a 13-item measure administered via patient and informant interviews to assess overall mood, physical and cognitive function, and quality of relationships in people with Alzheimer's Disease. Each item is scored 1 to 4, with higher score indicating better quality of life. Total score range from 13 to 52.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04123314
|Contact: Hillary Jacksonemail@example.com|
|United States, Maryland|
|Behavioral Pharmacology Research Unit||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Contact: Hillary Jackson 410-550-5466 firstname.lastname@example.org|
|Principal Investigator: Albert Garcia-Romeu, PhD|
|Principal Investigator: Paul B Rosenberg, MD|
|Principal Investigator:||Albert Garcia-Romeu, MD||Johns Hopkins University|