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| Name | Class |
|---|---|
| Berlin Institute of Health | OTHER |
| Federal Agency for Disruptive Innovation - SPRIN-D | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contraloid acetate | Experimental | 300 mg Contraloid/participant administered orally (for 28 days) as a single daily dose. Other Name: PRI-002 |
|
| Placebo | Placebo Comparator | 300 mg Placebo (Microcrystalline cellulose)/participant administered orally (for 28 days) as a single daily dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contraloid acetate | Drug | Oral administration of drug substance capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | Number of Adverse Events | 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 | From baseline (day 1) to follow-up (day 56) |
| Safety: Number of Participants with abnormal ECG values | ECG | From baseline (day 1) to follow-up (day 56) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Peak Plasma Concentration (Cmax) | Cmax in plasma | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Change of biomarkers in CSF | Biomarkers: p-tau, t-tau, NFL, Aβ 1-40, Aβ 1-42 and Aβ and tau oligomers | Baseline to end of treatment (day 28) to follow-up (day 56) |
| Efficacy: Change of biomarkers in plasma |
Inclusion Criteria:
Exclusion Criteria:
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
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité University Medicine | Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40324978 | Derived | 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. |
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| ID | Term |
|---|---|
| C109691 | microcrystalline cellulose |
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| Placebo | Drug | Oral administration of placebo without any exipients. |
|
|
Tmax in plasma
| 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 | pre-dose and 15 min, 1 hour, 2 hours, 4 hours post-dose at day 1 and day 28 |
Biomarkers: p-tau, t-tau, NFL, Aβ 1-40, Aβ 1-42 and Aβ and tau oligomers
| Baseline to end of treatment (day 28) to follow-up (day 56) |
| Efficacy optional: Change of biomarkers in feces | Biomarkers: p-tau, t-tau, NFL, Aβ 1-40, Aβ 1-42 and Aβ and tau oligomers | Baseline to end of treatment (day 28) to follow-up (day 56) |
| Efficacy: Change in CERAD+ test battery scores | Baseline to end of treatment (day 28) to follow-up (day 56) |
| Efficacy: Change in CDR-Sum of boxes | Baseline to end of treatment (day 28) to follow-up (day 56) |