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CompletedPhase 1

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

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

Asset

Contraloid

Listed sites

1

Recruiting sites

-

Enrollment

19

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•MCI due to AD•MMSE 22-30

Primary endpoint

•Safety

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDContraloidAD
NCT IDNCT04711486

Timeline

Milestones

Study start2020-12-08actual
Study first posted2021-01-15actual
Primary completion2022-01-13actual
Study completion2022-01-13actual
Last update posted2022-08-23actual

Assets

Drug assets

Contraloid

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
6
Tau biomarkers
3
Other (unclassified)
2

Tau biomarkers

3 endpoints
Other/protocol endpoint

Efficacy: Change of biomarkers in CSF

Time frame:Baseline to end of treatment (day 28) to follow-up (day 56)

Neurofilament light (NfL)

descriptive

Other/protocol endpoint

Efficacy: Change of biomarkers in plasma

Time frame:Baseline to end of treatment (day 28) to follow-up (day 56)

Neurofilament light (NfL)

descriptive

Other/protocol endpoint

Efficacy optional: Change of biomarkers in feces

Time frame:Baseline to end of treatment (day 28) to follow-up (day 56)

Neurofilament light (NfL)

descriptive

Safety / tolerability / PK

6 endpoints
Primary/protocol endpoint

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

Time frame:From baseline (day 1) to follow-up (day 56)

event count, event

Primary/protocol endpoint

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

Time frame:From baseline (day 1) to follow-up (day 56)

event count, event

Primary/protocol endpoint

Safety: Number of Participants with abnormal ECG values

Time frame:From baseline (day 1) to follow-up (day 56)

event count, event

Secondary/protocol endpoint

Pharmacokinetics: Peak Plasma Concentration (Cmax)

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

concentration, descriptive

Secondary/protocol endpoint

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

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

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics: Terminal elimination half-life (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

concentration, descriptive

Other (unclassified)

2 endpoints
Other/protocol endpoint/low confidence

Efficacy: Change in CERAD+ test battery scores

Time frame:Baseline to end of treatment (day 28) to follow-up (day 56)

change from baseline, improvement

Other/protocol endpoint/low confidence

Efficacy: Change in CDR-Sum of boxes

Time frame:Baseline to end of treatment (day 28) to follow-up (day 56)

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.