scholarly journals A pilot study of clinical cell therapies in Alzheimer’s disease

2021 ◽  
Vol 9 (4) ◽  
pp. 269-284
Author(s):  
Xiaoling Guo ◽  
Yunliang Wang ◽  
Yan Li ◽  
Yanqiu Liu ◽  
Ying Liu ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Pilot Study ◽  
Cell Therapy ◽  
Cell Types ◽  
Placebo Control ◽  
Clinical Dementia Rating ◽  
Olfactory Ensheathing Cell ◽  
Double Blind ◽  
Cell Therapies

Alzheimer’s disease (AD) is a neurodegenerative disease dominated by progressive cognitive dysfunction causing significant social, economic, and medical crises. Cell therapy has demonstrated favorable effects for AD. This pilot study examined the safety and neurorestorative effects of the olfactory ensheathing cell (OEC), olfactory neuron (ON), and Schwann cell (SC) on patients with AD. Seven patients with AD were enrolled in this two-center, randomized, double-blind, and placebo- controlled cell therapy study with a subsequent 12-month follow-up. We randomly assigned one or two participants in OEC, ON, and SC therapy or OEC combined with ON and placebo control. All enrolled patients were injected cells or medium into the olfactory sub-mucosa. They got an assessment of Mini-Mental State Examination, Montreal Cognitive Assessment, and Clinical Dementia Rating before treatment and 1, 3, 6, 12 months after treatment. We performed MRI or CT scans before treatment and 12 months after treatment. After integrating the results from the three evaluation methods, all cell types showed better results than a placebo control. ON and SC seem to exhibit more vital potential neurorestorative ability to enhance or convert the neurological functions of patients with AD, and OEC may help AD patients keep neurological functions stable. In this pilot study, there was no adverse or side-effect event. The results of this study strongly suggest conducting a phase II clinical trial of ON, SC, and OEC therapy to prove their neurorestorative effect on patients with AD.

Evaluating Thrombin Inhibition in Alzheimer’s Disease (The BEACON Trial): Protocol for a Pilot Study (Preprint)

2019 ◽  
Author(s):  
Cláudia Yang Santos ◽  
Christine Getter ◽  
John Stoukides ◽  
Brian Ott ◽  
Stephen Salloway ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Pilot Study ◽  
Cognitive Performance ◽  
Thrombin Inhibitor ◽  
Placebo Control ◽  
Open Label ◽  
Double Blind ◽  
Thrombin Inhibition ◽  
Approved Drugs

BACKGROUND The precise mechanisms whereby cardiovascular risk factors increase the risk of Alzheimer’s disease (AD) have not been delineated. We reported that microvessels isolated from AD brains overexpress a diverse array of neurotoxic and inflammatory proteins, which is consistent with the process of vascular activation. In pre-clinical studies using AD animal models we showed that a vascular activation inhibitor reduced vascular-derived neuroinflammation and improved cognitive performance. Thrombin is a key mediator of cerebrovascular activation in AD. OBJECTIVE This study aims to investigate the safety and potential efficacy of the direct thrombin inhibitor dabigatran, in patients with mild cognitive impairment (MCI) or mild AD to decrease vascular-derived neuroinflammation and improve cognitive performance. METHODS Participants will be enrolled then evaluated quarterly throughout the 24-month study. This is a 24-month randomized-control, double-blind, placebo-controlled, multicenter, delayed-start, pilot study evaluating thrombin inhibition in people with biomarker-confirmed MCI probably due to AD or mild AD. 40 - 60 participants will be recruited between 50 - 85 years old. In the initial 9-months of study, either dabigatran or placebo will be orally administered to patients at a dose of 150 mg per day. After 9 months of the placebo-control (Phase I), the placebo arm will cross-over to an active, open-label (Phase II) where all patients will be treated with a 150 mg daily dose of dabigatran orally for an additional 12 months. A 3-month non-treatment follow-up period will assess duration of effects. RESULTS Beginning in July 2019, and concluding in August 2022, this study is expected to publish final results in January 2023. CONCLUSIONS BEACON is a first-in-kind randomized clinical trial targeting thrombin activation in AD therapeutics. This trial will stimulate translational investigations of an FDA-approved drugs in a newly defined therapeutic areas. CLINICALTRIAL Clinicaltrials.gov NCT03752294

scholarly journals A pilot study of clinical cell therapy for patients with vascular dementia

2021 ◽  
Vol 9 (2) ◽  
pp. 137-150
Author(s):  
Yunliang Wang ◽  
Xiaoling Guo ◽  
Yanqiu Liu ◽  
Yan Li ◽  
Ying Liu ◽  
...  
Keyword(s):  
Pilot Study ◽  
Cell Therapy ◽  
Vascular Dementia ◽  
Clinical Dementia Rating ◽  
Double Blind ◽  
Cell Therapies ◽  
Group Patient ◽  
Verbal Recall ◽  
Human Lifespan ◽  
Age Related

Background:Vascular dementia (VD) is a series of clinical and neurophysiological manifestations caused by cerebrovascular disease. As the human lifespan increases, the number of people affected by age-related dementia is growing at an alarming pace, but no proved therapeutic methods can stop it from getting worse.Objective:To investigate the neurorestorative effects of injecting olfactory ensheathing cells (OECs), Schwann cells (SCs), and olfactory receptor neurons (ORNs) into olfactory sub-mucosa in VD patients.Methods:A pilot study of double-blind randomized controlled cell therapies was conducted in VD patients (n = 5). Cells were injected into the patients’ olfactory sub-mucosa. Two patients received OEC treatment, one received SC treatment, one ORN treatment, and one OEC combined with ORN. Mental state and cognitive function were observed before treatment and 1, 3, 6, and 12 months after treatment. magnetic resonance imaging (MRI) or computed tomography (CT) was performed before treatment and 12 months after treatment.Results:The directional function score on the Mini-Mental Status Examination (MMSE) in the patient who received SC treatment had increased slightly 1 and 3 months after treatment. The scores for orientation, attention, delayed verbal recall, and repetition increased in the ORN group patient 1 month after treatment. The orientation and repetition scores of the ORN group patient continued to increase 3 months after treatment. The scores for attention, delayed verbal recall, and phase 3 command decreased in the OEC and the OEC + ORN group patients after treatment assessment Scores on the Montreal Cognitive Assessment (MoCA) and Clinical Dementia Rating (CDR) scale also improved in the ORN group patient. Clinical and MRI or CT examinations did not find any side effects from the cell therapy or transplanting procedure.Conclusion:All of the cell transplantations were found to be safe. ORN was shown to be a promising therapy for VD patients. Phase II clinical trials of ORN, SC, and OEC therapy are required to verify their effects on VD symptoms, especially ORNs.

Mirtazapine does not improve sleep disorders in Alzheimer's disease: results from a double-blind, placebo-controlled pilot study

2016 ◽  
Vol 17 (2) ◽  
pp. 89-96 ◽  
Author(s):  
Francisca M. Scoralick ◽  
Luciana L. Louzada ◽  
Juliana L. Quintas ◽  
Janeth O.S. Naves ◽  
Einstein F. Camargos ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Pilot Study ◽  
Sleep Disorders ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals RE-PERG in early-onset Alzheimer’s disease: A double-blind, electrophysiological pilot study

PLoS ONE ◽  
2020 ◽  
Vol 15 (8) ◽  
pp. e0236568
Author(s):  
Alberto Mavilio ◽  
Dario Sisto ◽  
Florenza Prete ◽  
Viviana Guadalupi ◽  
Rosanna Dammacco ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Pilot Study ◽  
Early Onset ◽  
Double Blind ◽  
Early Onset Alzheimer’S Disease

P2-408: A double-blind, placebo-controlled, 18-month pilot study of the PPAR-gamma agonist pioglitazone in Alzheimer's disease

2006 ◽  
Vol 2 ◽  
pp. S366-S366 ◽  
Author(s):  
David S. Geldmacher ◽  
Thomas Fritsch ◽  
McKee J. McClendon ◽  
Alan J. Lerner ◽  
Gary E. Landreth
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Pilot Study ◽  
Ppar Gamma ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Ppar Gamma Agonist

Assessment of Motor and Process Skills as a Measure of IADL Functioning in Pharmacologic Studies of People With Alzheimer's Disease: A Pilot Study

1997 ◽  
Vol 9 (2) ◽  
pp. 197-206 ◽  
Author(s):  
Frances Oakley ◽  
Trey Sunderland
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Pilot Study ◽  
Motor Skills ◽  
Daily Living ◽  
Outcome Measure ◽  
Process Skills ◽  
Drug Trials ◽  
Double Blind ◽  
Significant Difference

The purpose of this pilot study was to evaluate the usefulness of the Assessment of Motor and Process Skills (AMPS) as an outcome measure of instrumental activities of daily living (IADL) in pharmacologic studies of people with Alzheimer's disease. The AMPS simultaneously measures motor and process skills and their effect on the ability of the person to perform familiar IADL tasks. We administered the AMPS to 11 Alzheimer inpatients in a 31/2-month, double-blind, placebo-controlled, crossover study of fluoxetine and selegiline administered as single agents and in combination with physostigmine. Results indicated that there was a significant difference in IADL ability among study conditions for process skills, but not for motor skills, thereby suggesting that the AMPS is useful as a sensitive outcome measure of IADL ability in drug trials with this population.

scholarly journals Double-blind Parallel Design Pilot Study of Acetyl Levocarnitine in Patients With Alzheimer's Disease

1992 ◽  
Vol 49 (11) ◽  
pp. 1137-1141 ◽  
Author(s):  
M. Sano ◽  
K. Bell ◽  
L. Cote ◽  
G. Dooneief ◽  
A. Lawton ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Pilot Study ◽  
Double Blind ◽  
Parallel Design
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