Alzheimer DiseasePhase 1NCT05077501
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of ACD856
A Phase 1 study testing ACD856 in people with Alzheimer Disease and Cognition Disorder, run by AlzeCure Pharma at 1 site in Sweden.
Trial summary
The multiple ascending dose (MAD) design of the study is based on the aim to study safety, tolerability, PK and pharmacodynamics of selected doses of ACD856 in a limited number of healthy volunteers. ACD856 will be administered orally. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Cognition Disorder
- What is being tested?
- ACD856
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- 29 Sep 2021to 23 May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent prior to any study-mandated procedure.
- Willing and able to comply with study requirements.
- Healthy male or female adults of non-childbearing potential aged ≥ 18 and ≤ 65 years at screening.
- Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 at screening.
- Only subjects of non-childbearing potential may be included in the study. Male subjects with partners of childbearing potential must be willing to use condoms, be vasectomised or practice sexual abstinence to prevent pregnancy and drug exposure of a partner, as well as refrain from donating sperm from the date of dosing until 3 months after dosing with the IMP.
- Clinically acceptable medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.
Who cannot join
- Any exposure to ACD856 in the past.
- Treatment with another investigational drug within 3 months prior to or during the study.
- Positive screen for drugs of abuse or a positive alcohol result at screening or admission to the clinic.
- Clinically relevant findings in laboratory parameters, ECG or vital signs at screening.
- Current smokers or subjects who use nicotine products.
- History of alcohol abuse or excessive intake of alcohol.
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- History of, or current use of, anabolic steroids.
- Excessive caffeine consumption.
- Plasma donation or blood donation prior to screening.
- Any planned night shift work within the duration of the study, from 48 h prior to randomisation until follow-up.
- Any planned major surgery within the duration of the study.
- Evidence of an active infection that requires treatment with antibiotics within 2 weeks of planned dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Phase I, Double-blind, Parallel-group, Placebo-controlled, Randomised Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Oral Doses of ACD856 in Healthy Volunteers
The multiple ascending dose (MAD) design of the study is based on the aim to study safety, tolerability, PK and pharmacodynamics of selected doses of ACD856 in a limited number of healthy volunteers.
ACD856 will be administered orally.
- Conditions
- Alzheimer Disease, Cognition Disorder
- Being tested
- ACD856, Placebo
- Keywords
- Alzheimer's Disease, Cognition Disorder
- Medical subject headings
- Alzheimer Disease, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACD856Drug
Multiple daily oral doses of ACD856 will be administered for 7 days in an escalation scheme of dose 1, dose 2 and dose 3. The escalation schedule may be adapted based on evaluation by the internal Safety Review Committee.
PlaceboDrug
Placebo oral solution
| Study group | Role | What they receive |
|---|---|---|
| ACD856 | Experimental | Not described Receives: Drug: ACD856 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events (AEs)
Number and percentage of subjects with adverse events (AEs).
Measured: 16 days
Clinically significant changes in 12-lead ECGs
Number of subjects and percentage of subjects with clinically significant changes in 12-lead ECGs
Measured: 16 days
Clinically significant changes in vital signs
Number of subjects and percentage of subjects with clinically significant changes in vital signs or stool frequency
Measured: 16 days
Clinically significant changes in hematology, clinical chemistry, coagulation and/or urinalysis parameters
Number of subjects and percentage of subjects with clinically significant changes in any safety laboratory assessments.
Measured: 16 days
Clinically significant changes in physical examinations
Number of subjects and percentage of subjects with clinically significant changes in physical examinations
Measured: 16 days
GAD-7
Change from baseline of GAD-7
Measured: 16 days
PHQ-9
Change from baseline of PHQ-9
Measured: 16 days
C-SSRS
Change from baseline of C-SSRS
Measured: 16 days
Prolactin
Change from baseline of prolactin levels
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start29 Sep 2021
- Primary completion16 May 2022
- Study completion23 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AlzeCure Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johan Sandin, PhD, Study director, AlzeCure Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077501
- Sponsor's protocol ID
- D2000CI-002
- Status last verified
- Jul 2022
- First submitted
- 1 Oct 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Phase I, Double-blind, Parallel-group, Placebo-controlled, Randomised Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Oral Doses of ACD856 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05077501
- Acronym / sponsor ID
- D2000CI-002
- Conditions
- Alzheimer Disease, Cognition Disorder
- Keywords
- Alzheimer's Disease, Cognition Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AlzeCure PharmaIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 16 May 2022 (actual)
- Study completion
- 23 May 2022 (actual)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The multiple ascending dose (MAD) design of the study is based on the aim to study safety, tolerability, PK and pharmacodynamics of selected doses of ACD856 in a limited number of healthy volunteers.
ACD856 will be administered orally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACD856 | Experimental | Drug: ACD856 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed and dated informed consent prior to any study-mandated procedure.
- Willing and able to comply with study requirements.
- Healthy male or female adults of non-childbearing potential aged ≥ 18 and ≤ 65 years at screening.
- Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 at screening.
- Only subjects of non-childbearing potential may be included in the study. Male subjects with partners of childbearing potential must be willing to use condoms, be vasectomised or practice sexual abstinence to prevent pregnancy and drug exposure of a partner, as well as refrain from donating sperm from the date of dosing until 3 months after dosing with the IMP.
Key exclusion criteria (12 listed)
- Any exposure to ACD856 in the past.
- Treatment with another investigational drug within 3 months prior to or during the study.
- Positive screen for drugs of abuse or a positive alcohol result at screening or admission to the clinic.
- Clinically relevant findings in laboratory parameters, ECG or vital signs at screening.
- Current smokers or subjects who use nicotine products.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACD856Multiple daily oral doses of ACD856 will be administered for 7 days in an escalation scheme of dose 1, dose 2 and dose 3. The escalation schedule may be adapted based on evaluation by the internal Safety Review Committee. | Drug | ACD856 |
| PlaceboPlacebo oral solution | Drug | Placebo |
Primary outcome
Frequency of adverse events (AEs)
Time frame: 16 days
Number and percentage of subjects with adverse events (AEs).
Clinically significant changes in 12-lead ECGs
Time frame: 16 days
Number of subjects and percentage of subjects with clinically significant changes in 12-lead ECGs
Clinically significant changes in vital signs
Time frame: 16 days
Number of subjects and percentage of subjects with clinically significant changes in vital signs or stool frequency
Clinically significant changes in hematology, clinical chemistry, coagulation and/or urinalysis parameters
Time frame: 16 days
Number of subjects and percentage of subjects with clinically significant changes in any safety laboratory assessments.
Clinically significant changes in physical examinations
Time frame: 16 days
Number of subjects and percentage of subjects with clinically significant changes in physical examinations
GAD-7
Time frame: 16 days
Change from baseline of GAD-7
PHQ-9
Time frame: 16 days
Change from baseline of PHQ-9
C-SSRS
Time frame: 16 days
Change from baseline of C-SSRS
Prolactin
Time frame: 10 days
Change from baseline of prolactin levels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Sandin, PhD study director
AlzeCure Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACD856 in people with Alzheimer Disease and Cognition Disorder, run by AlzeCure Pharma at 1 site in Sweden.
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 6 inclusion and 12 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: finished, as of the sponsor's last update on 20 Jul 2022. 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 Sweden. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of adverse events (AEs) (time frame: 16 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2022.