Evaluation of Safety of Contraloid Acetate in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease

NCT ID: NCT04711486

Last Updated: 2022-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-08
• Study Completion Date: 2022-01-13

Brief 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. 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.

Conditions

Mild Cognitive Impairment Due to Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Contraloid acetate

300 mg Contraloid/participant administered orally (for 28 days) as a single daily dose.

Other Name: PRI-002

Group Type: EXPERIMENTAL

Contraloid acetate

Intervention Type: DRUG

Oral administration of drug substance capsules

Placebo

300 mg Placebo (Microcrystalline cellulose)/participant administered orally (for 28 days) as a single daily dose.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral administration of placebo without any exipients.

Interventions

Contraloid acetate

Oral administration of drug substance capsules

Intervention Type: DRUG

Placebo

Oral administration of placebo without any exipients.

Intervention Type: DRUG

Other Intervention Names

PRI-002; Microcrystalline cellulose

Eligibility Criteria

Inclusion Criteria

1. Patients diagnosed with MCI due to AD according to DSM-V

2. Age between 50 and 80 years (male and female)

3. MMSE score 22-30

4. Written informed consent (according AMG §40 (1) 3b)

5. Level of Aβ-oligomers: mind. 1fM

6. CSF according to diagnosis (p-tau > 62 pg/ml, total CSF Aβ 1-42/1-40 ratio ≤ 0.055)

7. 3 months prior to screening stable medication

8. Females without childbearing potential

Exclusion Criteria

1. History of seizures

2. History of stroke or TIA

3. Unstable medical, neurological or psychiatric condition

4. 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
• 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

5. Persons who are legally detained in an official institution

6. Persons who may be dependent on the sponsor, the investigator or the trial site

7. Persons without caregiver

8. Participation in other clinical trials according to AMG (1 month before the time of this trial)

9. Persons showing EEG abnormalities

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Berlin Institute of Health

OTHER

Sponsor Role: collaborator

Federal Agency for Disruptive Innovation - SPRIN-D

UNKNOWN

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Oliver Peters, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Charité University Medicine

Berlin, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 40324978 (View on PubMed)

Other Identifiers

ContraloidAD

Identifier Type: -

Identifier Source: org_study_id