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A Phase 2 Theranostic Trial Evaluating the Effects of Thiethylperazine in Patients Diagnosed with an Early Stage of Alzheimer's disease

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501137-23-00
Acronym
IG-TEP-001
Enrollment
228
Registered
2022-11-02
Start date
Unknown
Completion date
2025-12-17
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly diagnosed early-to-mild dementia due to Alzheimer's Disease

Brief summary

The 2 arms (TEP-THX vs. PBO-THX) will be compared as regards the mean change in Florbetaben-PET SUVR at month 12, adjusted for baseline

Detailed description

Area under the curve (AUC), sensitivity and specificity for TEP-aided diagnosis at baseline (AD-DX vs. DC-DX), Differences between the groups (TEP-THX vs. PBO-THX) as regards GFAP, p-Tau181, Aβ42/40 ratio and NfL biomarkers in plasma at month 12, adjusted for baseline, Differences between the groups (TEP-THX vs. PBO-THX) as regards Aβ42/40 ratio, p-Tau181/total Tau ratio, and NfL, at month 12, adjusted for baseline, Differences between the groups (TEP-THX vs. PBO-THX) as regards iADRS, ADCS-Cog 13, FCSRT, ADCS-iADL, QoL-AD, NPI-Q and GDS levels at month 12, adjusted for baseline

Interventions

DRUGlactose monohydrate (67.66 mg)
DRUGcorn starch (11.94 mg)
DRUGmagnesium stearate
DRUGtalc
DRUGpolyglycol 6000
DRUGsucrose (33.7 mg)
DRUGcalcium carbonate
DRUGtitanium dioxide (E171)
DRUGpovidone 90 F
DRUGglycerol 85%
DRUGand montanglycol wax
DRUGNeuraceq 300 MBq/mL solution for injection
DRUGTorecan 6
DRUG5 mg obalené tablety

Sponsors

Immungenetics AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The 2 arms (TEP-THX vs. PBO-THX) will be compared as regards the mean change in Florbetaben-PET SUVR at month 12, adjusted for baseline—

Secondary

MeasureTime frame
Area under the curve (AUC), sensitivity and specificity for TEP-aided diagnosis at baseline (AD-DX vs. DC-DX), Differences between the groups (TEP-THX vs. PBO-THX) as regards GFAP, p-Tau181, Aβ42/40 ratio and NfL biomarkers in plasma at month 12, adjusted for baseline, Differences between the groups (TEP-THX vs. PBO-THX) as regards Aβ42/40 ratio, p-Tau181/total Tau ratio, and NfL, at month 12, adjusted for baseline, Differences between the groups (TEP-THX vs. PBO-THX) as regards iADRS, ADCS-Cog 13, FCSRT, ADCS-iADL, QoL-AD, NPI-Q and GDS levels at month 12, adjusted for baseline—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026