Mild Cognitive Impairment Due to Alzheimer's DiseasePhase 1NCT04711486
Evaluation of Safety of Contraloid Acetate in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease
A Phase 1 study testing Contraloid acetate in people with Mild Cognitive Impairment Due to Alzheimer's Disease, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Patients with mild cognitive impairment due to Alzheimer's disease (MCI due to AD) are at high risk to develop Alzheimer´s dementia. The therapeutic agent Contraloid has the potential to influence the chronic neurodegenerative process of AD. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Mild Cognitive Impairment Due to Alzheimer's Disease
- What is being tested?
- Contraloid acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteGermany
- Study dates
- 8 Dec 2020to 13 Jan 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with MCI due to AD according to DSM-V
- Age between 50 and 80 years (male and female)
- MMSE score 22-30
- Written informed consent (according AMG §40 (1) 3b)
- Level of Aβ-oligomers: mind. 1fM
- CSF according to diagnosis (p-tau > 62 pg/ml, total CSF Aβ 1-42/1-40 ratio ≤ 0.055)
- 3 months prior to screening stable medication
- Females without childbearing potential
Who cannot join
- History of seizures
- History of stroke or TIA
- Unstable medical, neurological or psychiatric condition
- Current treatment with one of the following substances:
- Typical antipsychotic or neuroleptic medication within 6 months of screening
- Anti-coagulation medications within 3 months of screening
Show all 14Show fewer
- Chronic use of opiates or opioids (including long-acting opioid medication) within 3 months of screening
- Stimulant medications (amphetamine, methylphenidate preparations, or modafinil) within 1 month of screening and throughout the study
- Chronic use of benzodiazepines, barbiturates, or hypnotics from 3 months before screening
- Persons who are legally detained in an official institution
- Persons who may be dependent on the sponsor, the investigator or the trial site
- Persons without caregiver
- Participation in other clinical trials according to AMG (1 month before the time of this trial)
- Persons showing EEG abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre, Randomized, Placebo-controlled, Double-blind, Phase 1b Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Contraloid Acetate in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease
Patients with mild cognitive impairment due to Alzheimer's disease (MCI due to AD) are at high risk to develop Alzheimer´s dementia. The therapeutic agent Contraloid has the potential to influence the chronic neurodegenerative process of AD. As Contraloid was so far only administered to healthy subjects, the rational of the proposed study is first to collect safety data in patients diagnosed with MCI due to AD, as the absorption, distribution, metabolism and excretion processes may be altered by disease, aging, comorbidities and concomitant drug therapies. Additionally, the design of a subsequent phase II study will be based on the data of this study. The results of the exploratory analyses will enable power calculations and the identification of the most useful and reliable biomarkers for the subsequent proof of concept phase II study.
- Being tested
- Contraloid acetate, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contraloid acetateDrug
Also called PRI-002
Oral administration of drug substance capsules
PlaceboDrug
Also called Microcrystalline cellulose
Oral administration of placebo without any exipients.
| Study group | Role | What they receive |
|---|---|---|
| Contraloid acetate | Experimental | 300 mg Contraloid/participant administered orally (for 28 days) as a single daily dose.
Other Name: PRI-002 Receives: Drug: Contraloid acetate |
| Placebo | Placebo comparator | 300 mg Placebo (Microcrystalline cellulose)/participant administered orally (for 28 days) as a single daily dose. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Number of Adverse Events
Measured: From baseline (day 1) to follow-up (day 56)
Safety: Number of Participants with abnormal laboratory values (urinalysis, CBC, Quick, PTT, Creatinine, CK, CRP, ALT, AST)
Laboratory values: urinalysis, CBC, Quick, PTT, Creatinine, CK, CRP, ALT, AST
Measured: From baseline (day 1) to follow-up (day 56)
Safety: Number of Participants with abnormal ECG values
ECG
Measured: From baseline (day 1) to follow-up (day 56)
Secondary outcomes (3)
Pharmacokinetics: Peak Plasma Concentration (Cmax)
Cmax in plasma
Measured: pre-dose and 15 min, 1 hour, 2 hours, 4 hours post-dose at day 1 and day 28
Pharmacokinetics: The time at which Cmax is observed (Tmax)
Tmax in plasma
Measured: pre-dose and 15 min, 1 hour, 2 hours, 4 hours post-dose at day 1 and day 28
Pharmacokinetics: Terminal elimination half-life (t1/2) in plasma
t1/2 in plasma
Measured: pre-dose and 15 min, 1 hour, 2 hours, 4 hours post-dose at day 1 and day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start8 Dec 2020
- Primary completion13 Jan 2022
- Study completion13 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive Impairment Due to Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Berlin Institute of Health, Federal Agency for Disruptive Innovation - SPRIN-D
- Responsible party
- Principal investigator, Oliver Peters, MD, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711486
- Sponsor's protocol ID
- ContraloidAD
- Status last verified
- Aug 2022
- First submitted
- 15 Dec 2020
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kutzsche J, Cosma NC, Kauselmann G, Fenski F, Bieniek C, Bujnicki T, Pils M, Bannach O, Willbold D, Peters O. Oral PRI-002 treatment in patients with MCI or mild AD: a randomized, double-blind phase 1b trial. Nat Commun. 2025 May 6;16(1):4180. doi: 10.1038/s41467-025-59295-z.
PubMed 40324978
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Randomized, Placebo-controlled, Double-blind, Phase 1b Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Contraloid Acetate in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04711486
- Acronym / sponsor ID
- ContraloidAD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Berlin Institute of Health, Federal Agency for Disruptive Innovation - SPRIN-D
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 13 Jan 2022 (actual)
- Study completion
- 13 Jan 2022 (actual)
- First posted
- 15 Jan 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.
Patients with mild cognitive impairment due to Alzheimer's disease (MCI due to AD) are at high risk to develop Alzheimer´s dementia. The therapeutic agent Contraloid has the potential to influence the chronic neurodegenerative process of AD. As Contraloid was so far only administered to healthy subjects, the rational of the proposed study is first to collect safety data in patients diagnosed with MCI due to AD, as the absorption, distribution, metabolism and excretion processes may be altered by disease, aging, comorbidities and concomitant drug therapies. Additionally, the design of a subsequent phase II study will be based on the data of this study. The results of the exploratory analyses will enable power calculations and the identification of the most useful and reliable biomarkers for the subsequent proof of concept phase II study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contraloid acetate | Experimental | Drug: Contraloid acetate300 mg Contraloid/participant administered orally (for 28 days) as a single daily dose. Other Name: PRI-002 |
| Placebo | Placebo comparator | Drug: Placebo300 mg Placebo (Microcrystalline cellulose)/participant administered orally (for 28 days) as a single daily dose. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients diagnosed with MCI due to AD according to DSM-V
- Age between 50 and 80 years (male and female)
- MMSE score 22-30
- Written informed consent (according AMG §40 (1) 3b)
- Level of Aβ-oligomers: mind. 1fM
Key exclusion criteria (14 listed)
- History of seizures
- History of stroke or TIA
- Unstable medical, neurological or psychiatric condition
- Current treatment with one of the following substances:
- Persons who are legally detained in an official institution
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 |
|---|---|---|
| Contraloid acetateAlso: PRI-002Oral administration of drug substance capsules | Drug | Contraloid acetate |
| PlaceboAlso: Microcrystalline celluloseOral administration of placebo without any exipients. | Drug | Placebo |
Primary outcome
Safety: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: From baseline (day 1) to follow-up (day 56)
Number of Adverse Events
Safety: Number of Participants with abnormal laboratory values (urinalysis, CBC, Quick, PTT, Creatinine, CK, CRP, ALT, AST)
Time frame: From baseline (day 1) to follow-up (day 56)
Laboratory values: urinalysis, CBC, Quick, PTT, Creatinine, CK, CRP, ALT, AST
Safety: Number of Participants with abnormal ECG values
Time frame: From baseline (day 1) to follow-up (day 56)
ECG
3 secondary outcomes
Pharmacokinetics: Peak Plasma Concentration (Cmax)
Time frame: pre-dose and 15 min, 1 hour, 2 hours, 4 hours post-dose at day 1 and day 28
Pharmacokinetics: The time at which Cmax is observed (Tmax)
Time frame: pre-dose and 15 min, 1 hour, 2 hours, 4 hours post-dose at day 1 and day 28
Pharmacokinetics: Terminal elimination half-life (t1/2) in plasma
Time frame: pre-dose and 15 min, 1 hour, 2 hours, 4 hours post-dose at day 1 and day 28
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 23 Aug 2022.
- Derived from this study: PubMed 40324978Kutzsche J, Cosma NC, Kauselmann G, Fenski F, Bieniek C, Bujnicki T, Pils M, Bannach O, Willbold D, Peters O. Oral PRI-002 treatment in patients with MCI or mild AD: a randomized, double-blind phase 1b trial. Nat Commun. 2025 May 6;16(1):4180. doi: 10.1038/s41467-025-59295-z.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Contraloid acetate in people with Mild Cognitive Impairment Due to Alzheimer's Disease, run by Charite University, Berlin, Germany at 1 site in Germany.
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 8 inclusion and 14 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 23 Aug 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 Germany. 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?
Safety: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 (time frame: From baseline (day 1) to follow-up (day 56)). The study lists 3 primary outcomes in all. 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 NCT04711486, which also lists 1 linked publication.
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 23 Aug 2022.