AzTrials
AzTrials

Alzheimer Disease (AD)Phase 1/2DAZA OPENNCT07091747

Use of a Product Containing the Cannabinoids CBD and THC as a Treatment Strategy for Alzheimer's Disease - Alzheimer's Disease and Cannabis Clinical Trial (DAZACANN) Open-Label Phase

A Phase 1/2 study testing Cannabis 50 mg of CBD and 5 mg of THC in people with Alzheimer Disease (AD), run by Federal University of Latin American Integration at 1 site in Brazil.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Alzheimer's Disease (AD) has become a significant public health issue due to the increase in its incidence from 2.0 to 16.8 cases per thousand people in a year, based on 2022 data. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Alzheimer Disease (AD)
What is being tested?
Cannabis 50 mg of CBD and 5 mg of THC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteBrazil
Study dates
7 Apr 2025to 12 Dec 2025
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have participated in and completed all assessments conducted in the first phase of the project.
  • Agree to and sign a new informed consent form.

Who cannot join

  • Patients who did not participate in the first stage.
  • Patients who began participating in the first stage but withdrew at any time.
  • Patients who do not agree and/or fail to sign the new informed consent form

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Universidade Federal da Integração Latino-Americana

    Foz do Iguaçu, Paraná, 85870-650

Other trials in Brazil

About this study

Alzheimer's Disease (AD) has become a significant public health issue due to the increase in its incidence from 2.0 to 16.8 cases per thousand people in a year, based on 2022 data. As many countries experience population aging, there is an increase in the prevalence of AD cases, which is the main form of dementia in the elderly. It commonly begins around the age of 60, with aging being the primary risk factor. AD is a neurodegenerative disorder characterized by the presence of extracellular beta-amyloid plaques and intracellular neurofibrillary tangles of Tau protein. Among the main symptoms of AD is progressive memory loss, with varying degrees of cognitive impairment. These symptoms share common clinical features such as a progressive decline in cognitive functions, including abstract thinking, judgment, language, personality changes, and behavioral symptoms, as well as the emergence of certain comorbidities.

As there are currently no curative treatments for this disease, pharmacotherapy aims to control the progressive symptoms, improving cognitive and functional aspects in patients, and consequently their quality of life. In this context, there is a need for further research to identify effective drugs that can delay or alleviate symptoms.

Read more

This study is part of the second phase of the project entitled: Use of a Product Containing the Cannabinoids CBD and THC as a Treatment Strategy for Alzheimer's Disease - Alzheimer's Disease and Cannabis Clinical Trial (DAZACANN): A randomized, double-blind, placebo-controlled clinical trial previously approved by the Human Ethics Committee - CEP (CAAE 60167722.6.0000.0107). The trial is being finalized at the Laboratory of Medicinal Cannabis and Psychedelic Science, located in the city of Foz do Iguaçu, Paraná, and will continue with a new experimental design, now as an open-label trial (all participants will receive the extract and will be informed about the formulation they are receiving).

The objective of this study remains to evaluate the clinical and biochemical effects of using cannabinoid-based products with low doses of purified CBD and THC, both individually and in combination, in patients with AD.

Being tested
Cannabis 50 mg of CBD and 5 mg of THC
Keywords
Alzheimer's Disease, Cannabidiol (CBD), Tetrahydrocannabinol (THC), Open Label
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cannabis 50 mg of CBD and 5 mg of THCOther

    Cannabis 50 mg of CBD and 5 mg of THC

Study groups in NCT07091747
Study groupRoleWhat they receive
Open label groupExperimentalThey will use the extract at a daily dose of 50 mg of CBD and 5 mg of THC from a product with a CBD:THC concentration of 50 mg/ml:5 mg/ml for a period of 24 months.
Receives: Other: Cannabis 50 mg of CBD and 5 mg of THC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mini Mental State Examination

    Assess cognitive function and disease progression. Cognitive function preserved (27 to 30 points), Mild cognitive impairment (21 to 26 points), Moderate cognitive impairment (10 to 20 points), Severe cognitive impairment (0 to 9 points).

    Measured: 24 months

Secondary outcomes (7)

  1. Neuropsychiatric Inventory

    Identify neuropsychiatric symptoms across different domains using the Neuropsychiatric Inventory. Score Range: 0-20 Mild symptoms or no significant impairment, 21-50 Moderate symptoms, 51-120 Severe symptoms with major impact

    Measured: 24 months

  2. Quality of Life in Alzheimer's Disease scale (QoL-AD)

    The scale has 3 versions, one of which is applied to the patient, another to the caregiver to answer about the patient's life, and one for the caregiver to answer about their own life. The score may vary, the one the investigators will use is the sum of the questionnaires about the patient, caregiver version and patient version, with the patient version having a weight of 2. Its score varies from 13, indicating the worst possible quality of life, up to 52, and the higher the score, the higher the quality of life.

    Measured: 24 month

  3. Epworth Sleepiness Scale (ESS )

    Evaluates 8 items with scores ranging from 0 to 24, in which scores higher than 10 indicate sleep disturbances.

    Measured: 24 month

  4. Specific markers of Alzheimer's disease

    The following proteins will be quantified in the cerebrospinal fluid: beta-amyloid 40, beta-amyloid 42, tau protein (fraction 181), and phosphorylated tau protein.

    Measured: 24 month

  5. Brain Derived Neurotrophic Factor

    It will be measured in serum or plasma

    Measured: 24 month

  6. Inflammatory markers

    TNFα (Tumor Necrosis Factor alpha), IL-6 (Interleukin-6), IL-1β (Interleukin-1 beta), and IL-10 (Interleukin-10), it will be measured in serum or plasma.

    Measured: 24 month

  7. Safety Endpoints - UKU Side Effect Rating Scale

    Will be conducted on patients and caregivers during all planned visits to ascertain the frequency and severity of adverse events. There will be neurological and physical examinations as well as laboratory testing. Total Score Sum of all 48 item scores (minimum 0; maximum 144), indicates greater overall severity of psychotropic side effects.

    Measured: 24 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2025
  2. Study start7 Apr 2025
  3. Primary completion12 Dec 2025 (estimated)
  4. Study completion12 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07091747
Sponsor's protocol ID
DAZACANN Open-Label Phase
Other IDs
CAAE: 86640925.4.0000.8527
Acronym
DAZA OPEN
Status last verified
Aug 2025
First submitted
21 Jul 2025
Last updated
12 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cannabis 50 mg of CBD and 5 mg of THC in people with Alzheimer Disease (AD), run by Federal University of Latin American Integration at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mini Mental State Examination (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07091747.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in