CompletedPhase 2

Study of Daratumumab in Patients With Mild to Moderate Alzheimer's Disease

United States16 participantsStarted 2019-11-06

Plain-language summary

This is an open-label, pilot study designed to explore whether daratumumab may have a clinically meaningful effect in patients with mild to moderate Alzheimer's disease.

Who can participate

Age range55 Years – 85 Years

SexALL

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Inclusion criteria

✓. Each subject must be ≥ 55 to ≤ 85 years of age at the screening visit.
✓. Each subject must have a diagnosis of probable AD dementia according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria.
✓. Each subject must have a Mini-Mental State Examination (MMSE) score ≥ 15 and ≤ 26 at the screening visit.
✓. Each subject must have a Magnetic Resonance Imaging (MRI) scan performed during the screening period that is consistent with a diagnosis of AD.
✓. Each subject must have a positive amyloid Positron Emission Tomography (PET) scan, either performed during the screening period, or previously performed provided that the scan and result are considered acceptable by the investigator.
✓. If the subject is receiving a cholinesterase inhibitor (donepezil, rivastigmine, or galantamine) and/or memantine, the dose must have been stable for at least 12 weeks before the screening visit, and the subject must be willing to remain on the same dose for the duration of the trial.
✓. Each subject must have a study partner who is reliable and competent. The study partner must have a close relationship with the subject, have face to face contact at least 3 days/week for a minimum of 6 waking hours/week, and be willing to accompany the subject to all required study visits.
✓. Each subject must have no clinically significant abnormal laboratory test results \[complete blood count (CBC), prothrombin time (PT)/international normalized ratio (INR), activated partial thromboplastin time (APTT), comprehensive metabolic panel (CMP), thyroid stimulating hormone (TSH), and vitamin B12 level\] at the screening visit.

Exclusion criteria

✕. The subject has a Rosen-modified Hachinski Ischemia Score \> 4 at the screening visit.
✕. The subject has a known history of stroke or evidence from screening MRI that is clinically significant in the investigator's opinion.
✕. The subject has evidence of a clinically relevant neurological disorder other than probable AD at the screening visit, including: vascular dementia, Parkinson's disease, dementia with Lewy bodies, frontotemporal dementia, progressive supranuclear palsy, corticobasal degeneration, amyotrophic lateral sclerosis, Huntington's disease, multiple sclerosis, mental retardation, hypoxic cerebral damage, or head trauma with loss of consciousness that led to persistent cognitive deficits.
✕. The subject has evidence of a clinically relevant or unstable psychiatric disorder, based on DSM-5 criteria, including schizophrenia or other psychotic disorder, bipolar disorder, delirium, or major depression. (Major depression in remission is not exclusionary.) A score on the 15-item Geriatric Depression Scale (GDS) of 5 or more requires an assessment by an appropriate health care professional to evaluate for the presence of major depression. Subjects with a score of 5 or more who are not diagnosed with major depression following such an assessment may be included in the trial.
✕. The subject has a history of alcoholism or drug dependency/abuse within the last 5 years before screening.
✕. The subject has been treated with any investigational product within 60 days or 5 half-lives (whichever is longer) prior to the screening visit.
✕. The subject has been treated with anti-amyloid-beta or anti-tau protein monoclonal antibodies within one year prior to the screening visit.
✕. The subject has been treated with an active vaccine targeting amyloid-beta or tau protein.

What they're measuring

Number of Participants With an Improvement of ≥ 4 Points on the ADAS-cog/11

Timeframe: 25 weeks

Trial details

NCT IDNCT04070378

SponsorMarc L Gordon, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-08

Results submitted2023-10-10

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