NCT04669028Phase 3Completed

A Phase 3 Study of NE3107 in Probable Alzheimer's Disease

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-09-30Actual

Enrollment · participants439Actual

Source updated2023-11-21Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Alzheimer Disease

Treatments or interventions studied

NE3107Drug
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB); description: test of 6 cognitive or functional domains, including memory, orientation, judgment, community affairs, home hobbies, and personal care are scored by certified raters after interviewing both participants and their informants. Higher score is indicative of more severe disease. The minimum score is 0 and the maximum score is 18. The CDR-SB is a co-primary outcome with ADAS-Cog12; timeFrame: baseline and week 30 (end of study); measure: Change in Alzheimer's Disease Assessment Scale Cognitive Subscale 12 [ADAS Cog12]; description: The ADAS-Cog was developed to assess the level of cognitive dysfunction in Alzheimer's disease. It is also used in studies of interventions in people with mild cognitive impairment. It is also used for assessing the efficacy of antidementia treatments. The test is administered and scored by a certified rater to assess the cognitive domains of memory, language, orientation and praxis. A higher score is indicative of more severe disease, with 0 (no cognitive deficit) being the lowest score possible and 80 being the highest score and associated with severe cognitive impairment. ADAS-Cog12 is a co-primary outcome with CDR-SB.; timeFrame: baseline and week 30 (end of study)

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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