Alzheimer DiseasePhase 1NCT04672135
A Phase 1 (First in Human) Randomized, Double-blind, Placebo-controlled SAD, MAD Study With Oral REM0046127
A Phase 1 study testing REM0046127 in people with Alzheimer Disease, run by reMYND at 1 site in Austria.
Trial summary
This is a phase 1 randomized double blind, first in human (FIH) study with the novel oral Alzheimer drug candidate REM0046127, which consists of two main parts, a single ascending dose (SAD) study with 7 cohorts followed by a multiple ascending dose (MAD) study with 2 cohorts. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- REM0046127
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteAustria
- Study dates
- 9 Nov 2020to 26 Apr 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- SAD/MAD: Young male subjects aged 18 to 45 years (limits included) willing and able to give their written consent to participate in the trial after having received information about the study design, the objectives of the project, the possible derivative risks, and their right to withdraw from the study at any time and for any reason
- Elderly Cohorts: Elderly male and female (not of childbearing potential) subjects aged 55 to 80 (limits included) willing and able to give their written consent to participate in the trial after having received information about the study design, the objectives of the project, the possible derivative risks, and their right to withdraw from the study at any time and for any reason.
- Women not of childbearing potential: Clinically significant abnormalities in screening laboratory tests, including:
- Surgically sterile (bilateral tubal ligation, hysterectomy), or
- Postmenopausal with last natural menses greater than 24 months
- Electrocardiogram without clinically significant pathologic abnormalities and with corrected QT interval (cQT) values lesser than 450 ms
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- Normotensive as defined by Systolic Blood Pressure ≤ 150 mm Hg. Diastolic Blood Pressure ≤ 90 mm Hg without antihypertensive medication
- Body Mass Index (BMI) between 18 and 30 kg/m2.
- Body weight between 60 and 80 kg, inclusive
- Only for the elderly cohort of the MAD:
- Participants may be taking medication for non-serious chronic diseases, provided that the dose of these concomitant medications has been stable within the previous 2 months
- No suicidal ideation, as demonstrated by a score of "0" on the Columbia Suicide Severity Rating Scale (C-SSRS)
Who cannot join
- Women of childbearing potential (WOCBP)
- Failure to perform screening or baseline examinations
- Any chronic medical condition (such as type 1 diabetes) requiring chronic treatment that might increase the risk to the subject or confound the interpretation of safety observations according to the clinical assessment of the investigator (physician)
- Evidence of active infection requiring antibiotic therapy within 14 days prior to screening
- Medical history of vasculitis or any autoimmune disease excluding seasonal allergic rhinitis and childhood history of atopic dermatitis
- History of any treatment for cancer within the past 2 years, other than basal cell or squamous cell carcinoma of the skin
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- Seropositive for human immunodeficiency virus (HIV)
- History of acute/chronic hepatitis B or C and/or carriers of hepatitis B (seropositive for Hepatitis B surface antigen [HbsAg] or anti-Hepatitis C [Hepatitis C Virus (HCV)] antibody)
- Clinically significant abnormalities in screening laboratory tests, including:
- Absolute neutrophil count < 1.4 x109
- Absolute lymphocyte count < 1.2 x 109
- Alanine transaminase (ALT) or aspartate transaminase (AST) > 1.5 x the upper limit of normal (ULN)
- Lactate Dehydrogenase (LDH) > 1.5 x ULN
- Total bilirubin level: Out of normal range 0-1.5 mg/dL
- Estimated glomerular filtration rate (eGFR) < 60 mL/min
- Haemoglobin (Hgb): out of normal range (male: 13,5-18,0 g/dL).
- Haemoglobin (Hgb): out of normal range (female: 12,0-16,0 g/dL)
- Use of an investigational drug within 2 months prior to dosing in this study
- Any disorder that could interfere with the absorption, distribution, metabolism or excretion of drugs (e.g. small bowel disease, Crohn's disease, celiac disease, or liver disease)
- Chronic kidney disease (defined as the presence of any degree of proteinuria on urine analysis and/or an eGFR of <60 ml/min using the (Modification of Diet in Renal Disease (MDRD) formula)
- Psychiatric history of current or past psychosis, bi-polar disorder, major depression, or anxiety disorder requiring chronic medication within the past 5 years
- History of substance abuse, including alcohol and nicotine or positive urine drug screen at screening visit
- Any reason or opinion of the investigator that would prevent the subject from participation in the study
- Inability to follow the instructions or an unwillingness to collaborate during the study
- Male subjects with female partner of child-bearing potential who are unwilling or unable to adhere to contraception requirements
- Only for the elderly cohort of the MAD:
- Chronic daily drug intake during the study period:
- Benzodiazepines, neuroleptics or major sedatives
- Antiepileptics
- Centrally active anti-hypertensive drugs (clonidine, l-methyl-DOPA, guanidine, guanfacine, etc.)
- Opioid containing analgesics
- History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years
- Clinically significant, advanced or unstable disease that may interfere with primary or secondary variable evaluations, and which may bias the assessment of the clinical or mental status of the volunteer or put the volunteer at special risk, such as:
- Chronic liver disease, liver function test abnormalities or other signs of hepatic insufficiency (Alanine-Aminotransferase (ALT), Aspartate-Aminotransferase (AST), Gamma Glutamyl-Transferase (GT), alkaline phosphatase > 2.0 ULN)
- Respiratory insufficiency
- Heart disease (myocardial infarction, unstable angina, heart failure, cardiomyopathy within six months before screening)
- Bradycardia (heartbeat <50/min) or tachycardia (heartbeat >95/min)
- Hypertension (<180/95) or hypotension requiring treatment with more than 2 drugs
- Atrioventricular (AV) block (type II / Mobitz II and type III), congenital long QT syndrome, sinus node dysfunction or prolonged QTcF-interval (males >450 and females >470 ms)
- Uncontrolled diabetes defined by HbA1c >8.5
- Renal insufficiency (serum creatinine > 2mg/dL) or creatinine clearance ≤ 30 mL/min according to Cockcroft-Gault formula).
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University Vienna, Department of Clinical Pharmacology
Vienna, 1090
About this study
Official title: A Phase 1 (First in Human) Randomized, Double-blind, Placebo-controlled SAD, MAD Study With an Adaptive Dose Design to Evaluate the Safety, Tolerability, and Pharmacokinetics of REM0046127 in Healthy Subjects
This is a phase 1 randomized double blind, first in human (FIH) study with the novel oral Alzheimer drug candidate REM0046127, which consists of two main parts, a single ascending dose (SAD) study with 7 cohorts followed by a multiple ascending dose (MAD) study with 2 cohorts.
Read the detailed description
SAD
As a baseline, 5 cohorts of 8 young healthy males are foreseen, with a repeat to assess food impact and an additional elderly cohort. Depending on the early FIH findings, the number of cohorts could be more or less. FIH studies include initially only males due to the incomplete nature of preclinical reproductive toxicology studies
- Treatment duration: single day
- Each cohort:
- 2 volunteers on placebos, of which 1 sentinel
- 6 volunteers on study drug, of which 1 sentinel
- Timing for each cohort will be about 21 days
- Subjects will be screened for selection from day -21 to day -1 before starting the experimental phase of each cohort
- First the 2 sentinels will be dosed
- Following the review of sentinel safety and tolerability data through the Data Safety Monitoring Board (DSMB) after one day or 2 half-life times following the sentinel dosing, the remaining 1+5 subjects will be randomized and dosed approximately 7 days after the sentinels
MAD
- First cohort of 10 healthy young male subjects. This cohort can be initiated after the food interaction has been assessed in the last safe SAD cohort, and does not need to wait for the elderly cohort.
- Second cohort of 12 healthy elderly subjects:
- The 1st cohort of healthy young male at about 75% of the Maximum Tolerated Dose (MTD) of the SAD
- The 2nd cohort of healthy older male and female (not of child-bearing potential) at about 50 or 100% of the highest tolerable dose of the SAD, depending on the observations in the 1st MAD cohort to assess potential impact of age on Pharmacokinetics (PK)
- Treatment duration: 7 days
- Timing for each cohort will be about 35 days
- Subjects will be screened for selection from day -21 to day -1 before starting the experimental phase each cohort
- First the sentinels will be dosed
- Following the review of sentinel safety and tolerability data through the DSMB, the remaining subjects will be randomized and dosed approximately 14 days later
- According to plan the sentinels of the 2nd cohort will be dosed about 35 days after the sentinels of the 1st cohort.
- Conditions
- Alzheimer Disease
- Being tested
- REM0046127, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REM0046127Drug
Oral solution: 100 mg/mL REM0046127
PlaceboDrug
Oral solution with 0 mg/mL REM0046127
| Study group | Role | What they receive |
|---|---|---|
| Study Drug | Active comparator | Each subject receives either a single dose (SAD) or a multiple dose (MAD) of REM0046127 as oral solution with a concentration of 100 mg/mL REM0046127. The starting dose for the first cohort in the SAD is 35mg up to a maximum of 2000mg at cohort 5. The starting dose for the MAD study is 0,75 of the Maximum Tolerated Dose (MTD) from the SAD. Receives: Drug: REM0046127 |
| Placebo | Placebo comparator | Each subject receives either a single (SAD) or multiple (MAD) dose of REM0046127 as oral solution with a concentration of 0 mg/mL REM0046127. The dose for each cohort is corresponding the amount of solution needed in the verum group. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number of Adverse Events either related or not related to treatment in the verum group in comparison to the placebo group
Measured: SAD: from dosing to 72 hours after dosing. MAD: from the first dosing until 48 hours after the last dosing on day 7.
SAD: Plasma Concentration including Peak Plasma Concentration (Cmax)
The plasma concentration during 48 hours after the dosing.
Measured: Plasma samples will be taken during SAD at baseline and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose.
SAD: Plasma Concentration including Half-Life(t1/2)
The plasma concentration during 48 hours after the dosing.
Measured: Plasma samples will be taken during SAD at baseline and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose.
SAD: Area under the Curve (AUC)
The AUC between baseline and 48 hour safter dosing.
Measured: Plasma samples will be taken during SAD at baseline and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose.
MAD: Half-Life(t1/2) between Baseline and 48 hours after the last dosing.
Half-Life(t1/2) between Baseline and 48 hours after the last dosing.
Measured: Plasma samples will be taken pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours post-dose, pre-dose on Day 5 and on Day 7: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours (Day 8) and 48 hours (Day 9).
MAD: Plasma Concentration
Peak Plasma Concentration (Cmax) between Baseline and 48 hours after the last dosing.
Measured: Plasma samples will be taken pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours post-dose, pre-dose on Day 5 and on Day 7: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours (Day 8) and 48 hours (Day 9).
MAD: Area under the Curve (AUC)
The AUC and steady-state volume of distribution(Vss) during the time interval from the first dose and 48 hour safterlast dose
Measured: Plasma samples will be taken pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours post-dose, pre-dose on Day 5 and on Day 7: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours (Day 8) and 48 hours (Day 9).
Cerebrospinal Fluid (CSF) PK (MAD)
In CSF the unbound brain/plasma partition coefficient (Kp,u) will be determined.
Measured: CSF samples will be collected on the last day of dosing (Day 7) at approximately Tmax determined during SAD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start9 Nov 2020
- Primary completion1 Apr 2022
- Study completion26 Apr 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
- Sequential
- Model description
- A Single Ascending Dose study with 6 Cohorts with 8 young male subjects each and 1 cohort with 4 male and 4 female subjects A Multiple Ascending Dose MAD study with 2 Cohorts: (Cohort 1: 10 young male subjects, Cohort 2: 6 elderly male and 6 elderly female (not of CBP) subjects.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- reMYND
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NeuroScios GmbH
- Responsible party
- Sponsor
- Investigators
- Nikola Helmberg, PhD, Study director, NeuroScios GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672135
- Sponsor's protocol ID
- NSC20002
- Status last verified
- May 2022
- First submitted
- 12 Nov 2020
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 (First in Human) Randomized, Double-blind, Placebo-controlled SAD, MAD Study With an Adaptive Dose Design to Evaluate the Safety, Tolerability, and Pharmacokinetics of REM0046127 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04672135
- Acronym / sponsor ID
- NSC20002
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- reMYNDIndustry (pharma, biotech, devices)
- Collaborators
- NeuroScios GmbH
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 26 Apr 2022 (actual)
- First posted
- 17 Dec 2020 (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.
This is a phase 1 randomized double blind, first in human (FIH) study with the novel oral Alzheimer drug candidate REM0046127, which consists of two main parts, a single ascending dose (SAD) study with 7 cohorts followed by a multiple ascending dose (MAD) study with 2 cohorts.
Detailed description
SAD
As a baseline, 5 cohorts of 8 young healthy males are foreseen, with a repeat to assess food impact and an additional elderly cohort. Depending on the early FIH findings, the number of cohorts could be more or less. FIH studies include initially only males due to the incomplete nature of preclinical reproductive toxicology studies
- Treatment duration: single day
- Each cohort:
- 2 volunteers on placebos, of which 1 sentinel
- 6 volunteers on study drug, of which 1 sentinel
- Timing for each cohort will be about 21 days
- Subjects will be screened for selection from day -21 to day -1 before starting the experimental phase of each cohort
- First the 2 sentinels will be dosed
- Following the review of sentinel safety and tolerability data through the Data Safety Monitoring Board (DSMB) after one day or 2 half-life times following the sentinel dosing, the remaining 1+5 subjects will be randomized and dosed approximately 7 days after the sentinels
MAD
- First cohort of 10 healthy young male subjects. This cohort can be initiated after the food interaction has been assessed in the last safe SAD cohort, and does not need to wait for the elderly cohort.
- Second cohort of 12 healthy elderly subjects:
- The 1st cohort of healthy young male at about 75% of the Maximum Tolerated Dose (MTD) of the SAD
- The 2nd cohort of healthy older male and female (not of child-bearing potential) at about 50 or 100% of the highest tolerable dose of the SAD, depending on the observations in the 1st MAD cohort to assess potential impact of age on Pharmacokinetics (PK)
- Treatment duration: 7 days
- Timing for each cohort will be about 35 days
- Subjects will be screened for selection from day -21 to day -1 before starting the experimental phase each cohort
- First the sentinels will be dosed
- Following the review of sentinel safety and tolerability data through the DSMB, the remaining subjects will be randomized and dosed approximately 14 days later
- According to plan the sentinels of the 2nd cohort will be dosed about 35 days after the sentinels of the 1st cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A Single Ascending Dose study with 6 Cohorts with 8 young male subjects each and 1 cohort with 4 male and 4 female subjects A Multiple Ascending Dose MAD study with 2 Cohorts: (Cohort 1: 10 young male subjects, Cohort 2: 6 elderly male and 6 elderly female (not of CBP) subjects.
| Arm | Type | Receives |
|---|---|---|
| Study Drug | Active comparator | Drug: REM0046127Each subject receives either a single dose (SAD) or a multiple dose (MAD) of REM0046127 as oral solution with a concentration of 100 mg/mL REM0046127. The starting dose for the first cohort in the SAD is 35mg up to a maximum of 2000mg at cohort 5. The starting dose for the MAD study is 0,75 of the Maximum Tolerated Dose (MTD) from the SAD. |
| Placebo | Placebo comparator | Drug: PlaceboEach subject receives either a single (SAD) or multiple (MAD) dose of REM0046127 as oral solution with a concentration of 0 mg/mL REM0046127. The dose for each cohort is corresponding the amount of solution needed in the verum group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- SAD/MAD: Young male subjects aged 18 to 45 years (limits included) willing and able to give their written consent to participate in the trial after having received information about the study design, the objectives of the project, the possible derivative risks, and their right to withdraw from the study at any time and for any reason
- Elderly Cohorts: Elderly male and female (not of childbearing potential) subjects aged 55 to 80 (limits included) willing and able to give their written consent to participate in the trial after having received information about the study design, the objectives of the project, the possible derivative risks, and their right to withdraw from the study at any time and for any reason.
- Women not of childbearing potential: Clinically significant abnormalities in screening laboratory tests, including:
- Electrocardiogram without clinically significant pathologic abnormalities and with corrected QT interval (cQT) values lesser than 450 ms
- Normotensive as defined by Systolic Blood Pressure ≤ 150 mm Hg. Diastolic Blood Pressure ≤ 90 mm Hg without antihypertensive medication
Key exclusion criteria (41 listed)
- Women of childbearing potential (WOCBP)
- Failure to perform screening or baseline examinations
- Any chronic medical condition (such as type 1 diabetes) requiring chronic treatment that might increase the risk to the subject or confound the interpretation of safety observations according to the clinical assessment of the investigator (physician)
- Evidence of active infection requiring antibiotic therapy within 14 days prior to screening
- Medical history of vasculitis or any autoimmune disease excluding seasonal allergic rhinitis and childhood history of atopic dermatitis
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 |
|---|---|---|
| REM0046127Oral solution: 100 mg/mL REM0046127 | Drug | Study Drug |
| PlaceboOral solution with 0 mg/mL REM0046127 | Drug | Placebo |
Primary outcome
Adverse Events
Time frame: SAD: from dosing to 72 hours after dosing. MAD: from the first dosing until 48 hours after the last dosing on day 7.
Number of Adverse Events either related or not related to treatment in the verum group in comparison to the placebo group
SAD: Plasma Concentration including Peak Plasma Concentration (Cmax)
Time frame: Plasma samples will be taken during SAD at baseline and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose.
The plasma concentration during 48 hours after the dosing.
SAD: Plasma Concentration including Half-Life(t1/2)
Time frame: Plasma samples will be taken during SAD at baseline and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose.
The plasma concentration during 48 hours after the dosing.
SAD: Area under the Curve (AUC)
Time frame: Plasma samples will be taken during SAD at baseline and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose.
The AUC between baseline and 48 hour safter dosing.
MAD: Half-Life(t1/2) between Baseline and 48 hours after the last dosing.
Time frame: Plasma samples will be taken pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours post-dose, pre-dose on Day 5 and on Day 7: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours (Day 8) and 48 hours (Day 9).
Half-Life(t1/2) between Baseline and 48 hours after the last dosing.
MAD: Plasma Concentration
Time frame: Plasma samples will be taken pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours post-dose, pre-dose on Day 5 and on Day 7: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours (Day 8) and 48 hours (Day 9).
Peak Plasma Concentration (Cmax) between Baseline and 48 hours after the last dosing.
MAD: Area under the Curve (AUC)
Time frame: Plasma samples will be taken pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours post-dose, pre-dose on Day 5 and on Day 7: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours (Day 8) and 48 hours (Day 9).
The AUC and steady-state volume of distribution(Vss) during the time interval from the first dose and 48 hour safterlast dose
Cerebrospinal Fluid (CSF) PK (MAD)
Time frame: CSF samples will be collected on the last day of dosing (Day 7) at approximately Tmax determined during SAD
In CSF the unbound brain/plasma partition coefficient (Kp,u) will be determined.
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 19 May 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.
Nikola Helmberg, PhD study director
NeuroScios GmbH
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 REM0046127 in people with Alzheimer Disease, run by reMYND at 1 site in Austria.
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 12 inclusion and 41 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 19 May 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 Austria. 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?
Adverse Events (time frame: SAD: from dosing to 72 hours after dosing. MAD: from the first dosing until 48 hours after the last dosing on day 7.). The study lists 8 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 19 May 2022.