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

Phase 1

Completed

• Conditions: Mild Cognitive Impairment Due to Alzheimer's Disease
• Interventions: Drug: Contraloid acetate; Drug: Placebo

• Registration Number: NCT04711486
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-08
• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-15
• Primary Completion: 2022-01-13
• Study Completion: 2022-01-13
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-22
• Last Update Posted: 2022-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Contraloid acetate	Contraloid acetate	300 mg Contraloid/participant administered orally (for 28 days) as a single daily dose. Other Name: PRI-002
Placebo	Placebo	300 mg Placebo (Microcrystalline cellulose)/participant administered orally (for 28 days) as a single daily dose.

Primary Outcome Measures

Name	Time	Method
Safety: Number of Participants with abnormal laboratory values (urinalysis, CBC, Quick, PTT, Creatinine, CK, CRP, ALT, AST)	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 Treatment-Related Adverse Events as Assessed by CTCAE v4.0	From baseline (day 1) to follow-up (day 56)	Number of Adverse Events
Safety: Number of Participants with abnormal ECG values	From baseline (day 1) to follow-up (day 56)	ECG

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics: Peak Plasma Concentration (Cmax)	pre-dose and 15 min, 1 hour, 2 hours, 4 hours post-dose at day 1 and day 28	Cmax in plasma
Pharmacokinetics: The time at which Cmax is observed (Tmax)	pre-dose and 15 min, 1 hour, 2 hours, 4 hours post-dose at day 1 and day 28	Tmax in plasma
Pharmacokinetics: Terminal elimination half-life (t1/2) in plasma	pre-dose and 15 min, 1 hour, 2 hours, 4 hours post-dose at day 1 and day 28	t1/2 in plasma

Trial Locations

Locations (1)

Charité University Medicine; 🇩🇪 Berlin, Germany