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

Primary Purpose

Mild Cognitive Impairment Due to Alzheimer's Disease

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Contraloid acetate

Placebo

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment Due to Alzheimer's Disease

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
- 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

Sites / Locations

Charité University Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Contraloid acetate

Placebo

Arm Description

300 mg Contraloid/participant administered orally (for 28 days) as a single daily dose. Other Name: PRI-002

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

Outcomes

Primary Outcome Measures

Safety: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

Number of Adverse Events

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

Safety: Number of Participants with abnormal ECG values

ECG

Secondary Outcome Measures

Pharmacokinetics: Peak Plasma Concentration (Cmax)

Cmax in plasma

Pharmacokinetics: The time at which Cmax is observed (Tmax)

Tmax in plasma

Pharmacokinetics: Terminal elimination half-life (t1/2) in plasma

t1/2 in plasma

Full Information

NCT ID

NCT04711486

First Posted

December 15, 2020

Last Updated

August 22, 2022

Sponsor

Charite University, Berlin, Germany

Collaborators

Berlin Institute of Health, Federal Agency for Disruptive Innovation - SPRIN-D

1. Study Identification

Unique Protocol Identification Number

NCT04711486

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

December 8, 2020 (Actual)

Primary Completion Date

January 13, 2022 (Actual)

Study Completion Date

January 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Charite University, Berlin, Germany

Collaborators

Berlin Institute of Health, Federal Agency for Disruptive Innovation - SPRIN-D

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment Due to Alzheimer's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Contraloid acetate

Arm Type

Experimental

Arm Description

300 mg Contraloid/participant administered orally (for 28 days) as a single daily dose. Other Name: PRI-002

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Contraloid acetate

Other Intervention Name(s)

PRI-002

Intervention Description

Oral administration of drug substance capsules

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Microcrystalline cellulose

Intervention Description

Oral administration of placebo without any exipients.

Primary Outcome Measure Information:

Title

Safety: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

Description

Number of Adverse Events

Time Frame

From baseline (day 1) to follow-up (day 56)

Title

Safety: Number of Participants with abnormal laboratory values (urinalysis, CBC, Quick, PTT, Creatinine, CK, CRP, ALT, AST)

Description

Laboratory values: urinalysis, CBC, Quick, PTT, Creatinine, CK, CRP, ALT, AST

Time Frame

From baseline (day 1) to follow-up (day 56)

Title

Safety: Number of Participants with abnormal ECG values

Description

ECG

Time Frame

From baseline (day 1) to follow-up (day 56)

Secondary Outcome Measure Information:

Title

Pharmacokinetics: Peak Plasma Concentration (Cmax)

Description

Cmax in plasma

Time Frame

pre-dose and 15 min, 1 hour, 2 hours, 4 hours post-dose at day 1 and day 28

Title

Pharmacokinetics: The time at which Cmax is observed (Tmax)

Description

Tmax in plasma

Time Frame

pre-dose and 15 min, 1 hour, 2 hours, 4 hours post-dose at day 1 and day 28

Title

Pharmacokinetics: Terminal elimination half-life (t1/2) in plasma

Description

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

Other Pre-specified Outcome Measures:

Title

Efficacy: Change of biomarkers in CSF

Description

Biomarkers: p-tau, t-tau, NFL, Aβ 1-40, Aβ 1-42 and Aβ and tau oligomers

Time Frame