Health TrialsbyHealthPanel

Rivastigmine Mini-Tablet for Alzheimer's Disease

ConditionAlzheimer's Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorPeking University First Hospital

About this trial

The objective of this study is to evaluate the efficacy and safety of rivastigmine mini-tablets in individuals diagnosed with mild to moderate Alzheimer's disease (AD).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 50 or older

Meet the National Institute of Aging-Alzheimer's Association clinical criteria for probable Alzheimer's disease

Have a Mini-Mental State Examination score of 10 to 24 at Screening and Baseline

Geriatric Depression Scale score <=7 at Screening

Disqualifiers

Any systemic or neurological condition that could contribute to cognitive impairment above and beyond that caused by the participant's Alzheimer's disease

Any psychiatric diagnosis or symptoms (hallucinations, major depression, delusions, etc) interfering with study procedures

An advanced, severe or unstable disease of any type (cardiac, respiratory, gastrointestinal, renal disease, etc) that may interfere with efficacy evaluations

Subjects treated with medication for dementia two weeks prior to baseline

Trial population

Patients with Alzheimer's disease

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Rivastigmine Mini-Tablet

    Drug

    Treatment group: Rivastigmine Mini-Tablet

  • Donepezil Hydrochloride

    Drug

    Control group: Donepezil Hydrochloride

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: Rivastigmine Mini-Tablet1 intervention
Group B: Donepezil Hydrochloride1 intervention

Trial outcomes

Primary outcomes

1

Changes from baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB)

CDR-SB range 0-18, with higher scores indicating more severe dementia.

Time frame
Baseline to 12 months

Secondary outcomes

1

Changes from baseline in Mini-Mental State Examination (MMSE) scale scores

MMSE range 0-30, with higher scores indicating better cognitve functioning.

Time frame
Baseline to 12 months
2

Changes from baseline in Neuropsychiatric Inventory (NPI) scale scores

NPI score range is 0-144 for patient assessment and 0-60 for caregiver distress assessment. In patient assessment, higher scores indicate more severe neuropsychiatric disorders; in caregiver distress assessment, higher scores indicate greater distress.

Time frame
Baseline to 12 months
3

Changes from baseline in Alzheimer's Disease Cooperative Study ADL（ADCS-ADL)） scores

ADCS-ADL range 0-78, with higher scores indicating better functional ability in daily activities.

Time frame
Baseline to 12 months
4

Concentration Changes from Baseline of Plasma Biomarkers (Aβ42/40, p - tau181, p - tau217, NfL and GFAP）

The plasma biomarkers include Aβ42/40，p-tau181, p-tau217, NfL and GFAP.

Time frame
Baseline to 12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University First Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: