Treatment of mild to moderate stage Alzheimer's disease patients. Nervous System Diseases
Conditions
Interventions
The study will recruit 12 mild to moderate-stage AD patients to perform 12 interventions, each spaced 3 days apart.
Notably, the study team found the mAb half-life to be approximately 18 hours in the
Sponsors
Islamic Azad University Medical Branch of Tehran
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female participants aged 55 to 85 years at the time of screening. 2. Participant who is informed of the clinical trial and signs a consent form (if unable to sign, consent from a legally acceptable representative is required). 3. Patient diagnosed with Mild-to-Moderate Stage AD according to the core clinical criteria outlined in National Institute on Aging (NIA) – Alzheimer's Association Diagnostic Guidelines (2011): 3.1. In the mild stage of Alzheimer’s disease, the symptoms might not be apparent; however, the patient may have difficulties performing social and work tasks, remembering recent information or names, choosing the right words, or misplacing valuable objects. 3.2. In the moderate stage, dementia symptoms become more pronounced, and the person may struggle with expressing thoughts and performing routine tasks without assistance (such as dressing, bathing, and eating). Symptoms can vary from person to person and may include forgetfulness, mood changes, confusion, difficulty with daily tasks, incontinence, changes in sleep patterns, wandering, and personality/behavioral changes. 4. Positive findings for AD in CSF (low Aß42 and high tau, p-tau protein levels) as measured via lumbar puncture at screening (or within 12 months before baseline) or positive amyloid PET scan within 12 months before baseline. 5. MMSE score at screening of 15-24, inclusive. 6. Participants should be maintained on stable doses of their medical therapy for AD for at least 4 weeks before the screening and baseline visits. 7. Willingness and ability to complete all study visits, confirmed by the physician. 8. Availability of a reliable person ("caregiver") who, in the investigator's judgment, has frequent and sufficient contact with the participant and is able to provide accurate information regarding the participant's cognitive and functional abilities, agrees to provide information at clinic visits, which require partner input for scale completion and signs the necessary consent form. 9. Patients with normal clinical laboratory values or, if abnormal, must be judged to be not clinically significant by the physician. 10. Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing.
Exclusion criteria
Exclusion criteria: 1. A diagnosis of dementia due to causes other than probable AD. 2. History of a clinically significant stroke (i.e., in the judgment of the investigator, could be a contributing cause of the participant's dementia). 3. Current evidence or history in the past two years of epilepsy, focal brain lesion, head injury with loss of consciousness, or DSM V criteria for any major psychiatric disorder, including psychosis, depression, bipolar disorder, alcohol, or substance abuse. 4. Sensory impairment that would preclude the participant from participating in the study or cooperating with the investigator. 5. Current evidence of any significant clinical disorder or laboratory finding, including severe or uncontrolled medical condition (including hematologic, hepatic, or renal conditions). 6. For participants who will undergo lumbar puncture, the contraindications include prior lumbosacral spine surgery, severe degenerative joint disease or deformity of the spine, history of bleeding, or platelet count ?100000. 7. History of any type of malignancies within the past five years, except for appropriately treated carcinoma in situ of the cervix, stable prostate cancer, or non-melanoma skin carcinoma. 8. Use of an investigational agent or participation in any trial within the last two months prior to the screening visit. 9. Have had prior or current treatment with ADUHELM® (Aducanumab). 10. History of or positive test result at Screening for hepatitis C virus antibody (HCV Ab), hepatitis B virus, positive PPD (defined as positive for hepatitis B surface antigen [HBsAg], hepatitis B core antibody [HbcAb]), or human immunodeficiency virus (VDRL-HIV-TFD). 11. Current drug abuse or alcohol addiction. 12. Chronic uncontrolled hypertension (average of 3 systolic blood pressure (SBP) and diastolic blood pressure (DBP) readings at Screening >165/=100 mmHg) or severe orthostatic hypotension. 13. Evidence of hydrocephalus or presence of a ventriculoperitoneal shunt.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety profile of AININ-20 will be assessed using the following methods: 1. Incidence of adverse events (AEs) including cardiovascular, psychiatric, extrapyramidal, injection site reactions, infections, and renal/liver complications measured using data collected in the Case Report Form at the end of the study 2. Evaluation of immediate and long-term AEs post-infusion measured using data collected in the Case Report Form at the end of the study 3. Physical examination, ECG, BMI and vital signs before and after infusion 4. Laboratory test results before and after infusion 5. Overall clinical improvement measured using the Clinical Global Impression (CGI) scale after infusion | — |
Secondary
| Measure | Time frame |
|---|---|
| The efficacy of AININ-20 in treating AD will be assessed using the following methods: 1. Cognitive function measured using the Mini-Mental State Examination (MMSE) before and after infusion 2. Cognitive function in areas like memory, language, attention, and orientation, measured using the Montreal Cognitive Assessment (MoCA) score before and after infusion 3. Visuo-motor pathway dysfunction measured using the Integrated Cognitive Assessment (ICA) score before and after infusion | — |
Countries
Iran
Contacts
Public ContactKoorosh Shahpasand
Outcome results
None listed