Status:
COMPLETED
Evaluation of Safety of Contraloid Acetate in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Berlin Institute of Health
Federal Agency for Disruptive Innovation - SPRIN-D
Conditions:
Mild Cognitive Impairment Due to Alzheimer's Disease
Eligibility:
All Genders
50-80 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2022
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04711486
Start Date
December 8 2020
End Date
January 13 2022
Last Update
August 23 2022
Active Locations (1)
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1
Charité University Medicine
Berlin, Germany, 10117