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

Charité University Medicine Berlin

Status and phase: Completed; Phase 1

Conditions: Mild Cognitive Impairment Due to Alzheimer's Disease

Treatments: Drug: Contraloid acetate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04711486

ContraloidAD

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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19 participants in 2 patient groups, including a placebo group

Contraloid acetate

Experimental group

Description:

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

Treatment:

Drug: Contraloid acetate

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo