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

Mild Cognitive Impairment Due to Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04711486
• Other study ID #: ContraloidAD
• Status: Completed
• Phase: Phase 1
• Start date: December 8, 2020
• Est. completion date: January 13, 2022

Study information

• Verified date: August 2022
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 13, 2022
• Est. primary completion date: January 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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 Aß-oligomers: mind. 1fM

6. CSF according to diagnosis (p-tau > 62 pg/ml, total CSF Aß 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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment Due to Alzheimer's Disease

Intervention

Drug:
• Contraloid acetate
Oral administration of drug substance capsules
• Placebo
Oral administration of placebo without any exipients.

Locations

Country	Name	City	State
Germany	Charité University Medicine	Berlin

Sponsors (3)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Berlin Institute of Health, Federal Agency for Disruptive Innovation - SPRIN-D

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Efficacy: Change of biomarkers in CSF	Biomarkers: p-tau, t-tau, NFL, Aß 1-40, Aß 1-42 and Aß and tau oligomers	Baseline to end of treatment (day 28) to follow-up (day 56)
Other	Efficacy: Change of biomarkers in plasma	Biomarkers: p-tau, t-tau, NFL, Aß 1-40, Aß 1-42 and Aß and tau oligomers	Baseline to end of treatment (day 28) to follow-up (day 56)
Other	Efficacy optional: Change of biomarkers in feces	Biomarkers: p-tau, t-tau, NFL, Aß 1-40, Aß 1-42 and Aß and tau oligomers	Baseline to end of treatment (day 28) to follow-up (day 56)
Other	Efficacy: Change in CERAD+ test battery scores		Baseline to end of treatment (day 28) to follow-up (day 56)
Other	Efficacy: Change in CDR-Sum of boxes		Baseline to end of treatment (day 28) to follow-up (day 56)
Primary	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)
Primary	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)
Primary	Safety: Number of Participants with abnormal ECG values	ECG	From baseline (day 1) to follow-up (day 56)
Secondary	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
Secondary	Pharmacokinetics: The time at which Cmax is observed (Tmax)	Tmax in plasma	pre-dose and 15 min, 1 hour, 2 hours, 4 hours post-dose at day 1 and day 28
Secondary	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