CBD for Individuals at Risk for Alzheimer's Disease
ConditionMild Cognitive Impairment
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55-85
SponsorUniversity of Colorado, Denver
About this trial
This is a double-blind, randomized controlled trial designed to test the effects of cannabidiol (CBD) on validated biomarkers of Alzheimer's disease (AD) progression, and behavioral, neurocognitive, and clinical measures, with putative mechanisms of action.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must be between the ages of 55 - 85 and provide valid informed consent.
Participant must receive a diagnosis of Mild Cognitive Impairment after a careful cognitive and functional evaluation by a clinician, or have symptoms of Mild Cognitive Impairment as determined by the study physician.
Functional Activities Questionnaire (FAQ) score of 8 or less and self-reported ability to function independently.
Montreal Cognitive Assessment (MoCa) score is ≤ 25
Disqualifiers
Any other central nervous system (CNS) disease that would be expected to affect cognition, Parkinson's disease, multiple sclerosis.
History of brain injury resulting in current memory loss symptoms (e.g., concussion with significant loss of consciousness)
Any significant systemic illness or unstable medical condition
Current use of Parkinson's medications, antipsychotic medications, anti-seizure medications, or anticholinergic medications
Trial design
Design model
Parallel
Treatments tested in this trial
Cannabidiol
DrugThe current study will directly test the hypothesis that a moderate dose of CBD improves markers of Alzheimer's progression, cognitive function, sleep, pain, anxiety, oxidative stress, and inflammation.
Placebo
Other interventionPlacebo arm.
Treatment groups
236 Participants
are divided into 3 treatment groupsGroup A: Full Spectrum CannabidiolActive comparator 1 intervention
Group B: Broad Spectrum CannabidiolActive comparator 1 intervention
Group C: Hemp Seed OilPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Neurocognitive Function
The following assessments will be used to inform an aggregate measure of neurocognitive function: * The Clinical Dementia Rating Scale is a 5-point scale used to characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias. Higher scores indicate worse cognitive impairment. * NIH-Toolbox Cognitive Battery (NIH-TB CB) assessments are used to detect and measure specific aspects of cognition, including crystallized intelligence, psychomotor function, executive function, attention, and working memory. * Rey Auditory Verbal Learning Test to evaluate working memory and the Digit Symbol Substitution Task to evaluate global cognitive operations. * Montreal Cognitive Assessment (MoCa) * Functional Activities Questionnaire (FAQ) will be used to measure changes in dementia risk over the course of the clinical trial.
Time frame
Week 0 to Week 242
Biomarkers of Alzheimer's Disease Progression
* Changes in plasma levels of N-p-tau181 will be measured in ng/dl. * Changes in plasma Aβ42/Aβ40 ratio will be measured in ng/dl. * Changes in plasma Neurofilament Light (Nfl) will be measured in ng/dl.
Time frame
Week 0 to Week 24Secondary outcomes
1
Change in pain
* The PROMIS Pain Intensity 1a questionnaire consists of two items asking about the participant's level of pain on average and at its worst in the past 7 days. Participants are asked to rate their pain on a scale from 0 (no pain) to 10 (worst imaginable pain). * The PROMIS Short Form v1.1 - Pain Interference - 6b scale will be used to assess how disruptive pain was over the past 7 days. There are six questions with a total score of 30-higher scores indicate more interference.
Time frame
Week 0 to Week 242
Change in sleep
* The PROMIS Sleep Disturbance 4a assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. Scores range from 4-20, with higher scores indicating worse sleep outcomes. * The PROMIS Sleep-Related Impairment 4a assesses perceptions of alertness, sleepiness, tiredness, and perceived functional impairments during usual waking hours due to sleep problems. Scores range from 4-20, with higher scores indicating worse sleep-related impairment. * The PROMIS Short Form v1.0 - Fatigue 4a measures subject fatigue over the past 7 days. Scores range from 4-20, with higher scores indicating more fatigue.
Time frame
Week 0 to Week 243
Change in anxiety
-The Depression Anxiety Stress Scale is a 21-item self-report instrument for measuring the three related negative emotional states of depression, anxiety, and tension/stress. Higher scores indicate worse anxiety
Time frame
Week 0 to Week 244
Change in plasma lipid biomarkers of inflammation and oxidative stress
Change in plasma levels of 5-iso PGF2αVI, 16-HETE, PGD2 will be measured in ng/dl.
Time frame
Week 0 to Week 24Sponsors and contacts
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Source ClinicalTrials.gov